[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Rules and Regulations]
[Pages 37030-37056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18287]



[[Page 37029]]

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Part VI





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Parts 101 and 120



Food Labeling: Warning and Notice Statement: Labeling of Juice 
Products; Final Rule



Hazard Analysis and Critical Control Point (HACCP); Procedures for the 
Safe and Sanitary Processing and Importing of Juice; Extension of 
Comment Period; Proposed Rule

Federal Register / Vol. 63, No. 130 / Wednesday, July 8, 1998 / Rules 
and Regulations

[[Page 37030]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N-0524]
RIN 0910-AA43


Food Labeling: Warning and Notice Statement; Labeling of Juice 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising its food 
labeling regulations to require a warning statement on fruit and 
vegetable juice products that have not been processed to prevent, 
reduce, or eliminate pathogenic microorganisms that may be present. FDA 
is taking this action to inform consumers, particularly those at 
greatest risk, of the hazard posed by such juice products. FDA expects 
that providing this information to consumers will allow them to make 
informed decisions on whether to purchase and consume such juice 
products, thereby reducing the incidence of foodborne illnesses and 
deaths caused by the consumption of these products.

DATES: Effective September 8, 1998; however, compliance for juice other 
than apple juice or apple cider is not required until November 5, 1998.

FOR FURTHER INFORMATION CONTACT:  Geraldine A. June, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 28, 1997 (62 FR 45593), FDA 
published a notice of intent (``the notice of intent'') that announced 
a comprehensive program to address the incidence of foodborne illness 
related to consumption of fresh juice and ultimately to address the 
safety of all juice products. In the notice of intent, the agency 
invited comment on the appropriateness of its strategy to: (1) Initiate 
rulemaking on a mandatory Hazard Analysis and Critical Control Point 
(HACCP) program for some or all juice products; (2) propose that the 
labels or the labeling of juice products not specifically processed to 
prevent, reduce, or eliminate pathogens bear a warning statement 
informing consumers of the risk of illness associated with consumption 
of the product; and (3) initiate several educational programs to 
minimize the hazards associated with consumption of fresh juices. The 
agency stated that it would address comments received within 15 days of 
publication of the notice of intent as part of any rule proposed by the 
agency and would consider all comments to the notice of intent received 
after 15 days in any final rulemaking.
    FDA considered the comments received within 15 days of the notice 
of intent and other information available to the agency. Based on this 
information, FDA tentatively concluded in a proposed rule (``the HACCP 
proposal'') (63 FR 20450, April 24, 1998) that the most effective way 
to ensure the safety of juice products is to process the products under 
a system of preventive control measures. Consequently, in the HACCP 
document, the agency proposed to require that juice products be 
processed under HACCP programs.
    Although FDA had tentatively concluded that HACCP is the most 
effective means of ensuring the safety of juice products, it also 
tentatively concluded in a proposed rule (``the juice labeling 
proposal'') (63 FR 20486, April 24, 1998), that there is an immediate 
need to inform consumers of the health risks associated with the 
consumption of juice products not processed to prevent, reduce, or 
eliminate pathogens that may be present. As fully discussed in the 
juice labeling proposal, FDA proposed that packaged untreated juice 
products\1\ bear a warning statement informing at-risk consumers of the 
hazard posed by untreated juices to allow them to make informed 
decisions on whether to purchase and consume such products. Interested 
parties were given until May 26, 1998, to comment.
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    \1\ As discussed in the juice labeling proposal, the terms 
``juice'' and ``juice products'' are used interchangeably. Thus, 
``juice'' refers both to beverages that are composed exclusively of 
an aqueous liquid or liquids extracted from one or more fruits or 
vegetables and those beverages that contain other ingredients in 
addition to juice. Similarly, ``juice product'' refers both to 
beverages that contain only juice and beverages that are composed of 
juice and other ingredients.
    In the remainder of this document, products not processed to 
prevent, reduce, or eliminate pathogens will be referred to as 
``untreated juice products.'' In addition, processing to ``prevent, 
reduce, or eliminate'' pathogens will be referred to as processing 
to ``control'' pathogens.
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    FDA prepared a single Preliminary Regulatory Impact Analysis (PRIA) 
that addressed both the juice labeling proposal and the HACCP proposal 
(63 FR 24254, May 1, 1998). Interested parties were given until May 26, 
1998, to comment on aspects of the PRIA relating to the juice labeling 
proposal and until July 8, 1998, to comment on aspects of the PRIA 
relating to the HACCP proposal. Elsewhere in this issue of the Federal 
Register, FDA is announcing a 30-day extension of the comment period on 
the juice HACCP proposal to August 7, 1998.
    FDA received approximately 85 responses to the notice of intent, 
each containing one or more comments. FDA addressed some of these 
comments in the juice labeling proposal. FDA subsequently received 
approximately 150 responses to the juice labeling proposal, each 
containing one or more comments. Responses to the notice of intent and 
to the juice labeling proposal were received from industry, trade 
organizations, consumers, consumer interest groups, academia, and State 
government agencies. Some of the comments supported the proposal. Other 
comments opposed the proposal or suggested modifications of various 
provisions of the proposal. The agency discusses below the significant 
comments bearing on the proposed labeling regulation and, when 
applicable, any revisions to the proposed regulation made in response 
to these comments. Responses to the notice of intent that bear on the 
juice labeling proposal and that were not addressed in that proposal 
are also addressed in this document. For simplicity, the agency's 
discussion does not categorize comments with regard to whether they 
were received in response to the notice of intent or in response to the 
juice labeling proposal.
    Proposed Sec. 101.17(g)(6) of the juice labeling proposal states 
that the requirements of that regulation would not apply to juice 
processed in a manner that will produce, at a minimum, a 5-log (i.e., 
100,000-fold) reduction in the pertinent microorganism for a period at 
least as long as the shelf life of the product when stored under normal 
and moderate abuse conditions, where the ``pertinent microorganism'' is 
the most resistant microorganism of public health significance that is 
likely to occur in the juice. This provision is directly linked to the 
process controls for pathogen reduction (the pathogen reduction 
performance standard; proposed Sec. 120.24 that is part of the agency's 
HACCP proposal. This standard is pivotal in both the juice labeling and 
juice HACCP proposals, and interested persons could comment on the 
standard in response to either or both proposals.
    FDA received several requests to extend the comment period, e.g., 
for an additional 30 days, for an additional 45 days, or for an 
additional 60 days. Some of these requests discussed the fact that the 
proposed pathogen reduction performance standard was an important

[[Page 37031]]

provision of both the juice labeling proposal and the HACCP proposal 
and stated that 30 days was an insufficient time to address that 
standard. In a memorandum dated June 5, 1998, from the Deputy Director 
of FDA's Regulations Policy and Management Staff to the Dockets 
Management Branch, FDA extended the comment period until June 22, 1998, 
for those persons who had requested an extension, in accordance with 
Sec. 10.40(b)(3) (21 CFR 10.40(b)(3)). Thereafter, in a memorandum 
dated June 10, 1998, FDA extended the comment period until June 22, 
1998, for all interested persons. The agency's memoranda noted that 
comments submitted to the juice labeling rule must be received in the 
Dockets Management Branch on or before 4:30 p.m., e.d.t., June 22, 
1998, and that no other extensions would be considered. The public was 
notified of both extensions by placing copies of the two memoranda in 
the agency's public docket.
    In this document FDA addresses those comments that were received on 
or before 4:30 p.m., e.d.t., June 22, 1998, in response to the notice 
of intent, in response to the juice labeling proposal, or in response 
to the HACCP proposal that bear on the proposed warning statement 
requirement or on the proposed pathogen reduction performance standard. 
However, in this document, FDA does not address any comments, received 
either in response to the notice of intent or in response to the juice 
labeling proposal, that bear on aspects of the HACCP proposal other 
than the pathogen reduction performance standard (proposed 
Sec. 120.24). Those comments will be addressed in any final rule that 
the agency issues with respect to the HACCP proposal.
    As noted, since the publication of the notice of intent in August 
1997, FDA has intended to propose two regulations, a juice HACCP 
regulation and a juice warning statement regulation, that in 
combination with one another, as well as certain educational programs, 
would establish a comprehensive program to ensure the safety of fresh 
juice. As discussed in the juice labeling proposal, the warning 
statement requirement is designed to provide public health information 
during the development and implementation of a HACCP rule. FDA 
recognizes that as a result, certain provisions of the juice labeling 
proposal and the juice HACCP proposal are very closely linked, 
including the scope of each rule (e.g., what is defined as ``juice'') 
and the pathogen reduction standard (the so-called ``5-log standard''). 
See also comment 40. The agency is also aware that the comment period 
announced in the juice HACCP proposal is continuing, and in fact, 
elsewhere in this issue of the Federal Register, the agency is 
announcing a 30-day extension of that comment period to August 7, 1998. 
Thus, comments are likely to be made on the HACCP proposal, including 
on these common issues, after the publication of this final rule.
    Although there are these overlapping issues in the two juice 
rulemakings, FDA believes that the public health risk presented by 
untreated juice is such that it is essential that the warning statement 
rulemaking be completed and the rule implemented promptly. In order to 
complete the warning statement rulemaking, the agency must consider and 
respond to all significant comments on the juice labeling proposal, 
including those comments that relate to issues presented in both the 
HACCP and warning statement rulemakings. Thus, this final rule 
addresses and responds to all significant comments made on the juice 
labeling proposal; the resolution of these comments is based upon the 
administrative record of this proceeding at this time. Once the comment 
period closes on the HACCP proposal, FDA will evaluate all comments 
received on that proposal and utilize such information to develop a 
final HACCP rule for juice, if such a rule is supported by the record. 
To the extent that the agency's analysis of the record for the HACCP 
proceeding results in the resolution of a common issue or issues in a 
way that differs from the issue's resolution in this final rule, FDA 
will initiate the amendment of the juice labeling regulation to ensure 
conformance with any final HACCP rule.

II. Rationale for Warning Statement

A. Risk Associated with Consumption of Juices

    In the notice of intent and the juice labeling proposal, FDA 
documented that certain juices have been the vehicle for outbreaks of 
foodborne illness (62 FR 45593). Consequently, in the juice labeling 
proposal, FDA proposed to require a warning statement for juice 
products to alert consumers, especially those at greatest risk, of the 
potential hazard so that they may make informed decisions on whether to 
purchase and consume such juice products.
    1. Some comments contended that FDA has not conducted an adequate 
risk assessment and, therefore, has no basis to require a warning 
statement.
    The agency performed a detailed evaluation of the hazards posed by 
untreated juices, which was filed in the administrative record of the 
HACCP proposal and was included as an appendix to the PRIA (Ref. 1). 
This evaluation was based on available scientific information and was 
appropriate to the circumstances. FDA believes that this evaluation 
provided an adequate assessment of risks and a sufficient basis for 
requiring a warning statement.
    2. Many of the comments contended that the health hazard associated 
with juice products is not sufficient to justify a warning statement. 
Some of the comments asserted that the health hazard is limited to 
apple juice and, therefore, the remedies should be limited to apple 
juice. Another comment asserted that FDA's estimate of the risk of 
foodborne illness is inaccurate because that estimate did not consider 
recent steps taken by members of the juice industry to address 
microbial contamination. Some comments argued that most of the 
outbreaks have occurred because of poor manufacturing practices and 
suggested that FDA increase its inspection of food manufacturers rather 
than issue regulations to require a warning statement.
    The agency does not agree with the comments that contend that the 
health hazard associated with the consumption of fresh juices is 
insufficient to justify requiring a warning statement. Risk is a 
function of two factors: Likelihood of occurrence of an event and 
severity of the event. As discussed in the HACCP proposal (63 FR 20450 
at 20459), severity is the seriousness of the consequences of exposure 
to the hazard. Considerations of severity (e.g., impact of sequelae and 
magnitude and duration of illness or injury) can be helpful in 
understanding the public health impact of the hazard. Likelihood of 
occurrence of a hazard is generally judged based on processing 
experience, epidemiological data, and information in the technical 
literature.
    As discussed in the juice labeling proposal, there are documented 
cases of foodborne illness associated with the consumption of various 
juice products contaminated with microorganisms such as Escherichia 
coli O157:H7, Salmonella species, Cryptosporidium, and Vibrio cholerae. 
These various microorganisms, which were found in apple juice, apple 
cider, orange juice, and frozen coconut milk, were associated with 
foodborne illness throughout the United States (e.g., in CA, CO, MA, 
NY, CT, NJ, MD, and WA) over a 6-year period (i.e., 1991 to 1996).

[[Page 37032]]

 Furthermore, some of the illnesses associated with certain untreated 
juice have been very severe (e.g., cases of long-term reactive 
arthritis and severe chronic illness); in one case, consumption of 
contaminated juice has resulted in death. As is the case with most food 
associated disease, because of the likelihood of underreporting, it is 
assumed that these outbreaks represent a fraction of the outbreaks and 
sporadic cases that actually occur.
    Importantly, the comments did not provide the agency with 
additional data that either contradict FDA's detailed hazard evaluation 
(Ref. 1) or that could be used to reevaluate the health risks 
associated with consumption of untreated juice products. Therefore, the 
comments have not persuaded FDA that there is insufficient risk to 
warrant requiring a warning statement for untreated juice products.
    The agency recognizes the recent steps taken by members of the 
juice industry to address microbial contamination. However, FDA notes 
that industry practices may vary. The agency is not aware that all 
members of the juice industry are addressing the potential for 
microbial contamination in an equally effective manner. Accordingly, 
the agency continues to see a need for a comprehensive Federal 
regulatory approach for all juice products.
    FDA tentatively concluded in the HACCP proposal (63 FR 20450 at 
20456) that a preventive system, such as HACCP, appears to offer the 
most effective long-term solution to control the significant microbial 
hazards, along with other hazards, that have become a problem with 
juice. Increased inspection, while having some beneficial impact on the 
safety of juices, is resource intensive to the agency. Even if funds 
were available to the agency for this purpose, the agency tentatively 
concluded in the HACCP proposal that increased inspection likely would 
not be the best way for the agency to utilize its resources to protect 
the public health. It is ultimately the responsibility of manufacturers 
to ensure that their products are safe.
    Current good manufacturing practices (CGMP's) are plantwide 
operating procedures that also address sanitation. Although FDA 
supports the use of CGMP's, the agency also tentatively concluded in 
the proposed HACCP rule that the use of CGMP's alone would not be 
sufficient to control the problems with juices because CGMP's do not 
concentrate on the identification and prevention of food hazards.
    Based on information the agency has received in response to the 
juice labeling proposal, FDA has concluded that the use of CGMP's and 
increased FDA inspections by themselves do not adequately address the 
safety of juices. Labeling addresses the need to provide a warning to 
consumers until juice processors implement measures to control 
pathogens.
    3. Comments stated that the results of FDA's 1997 national cider 
mill survey indicate that the health risk posed by cider is not 
sufficient to warrant a warning label. Although the results of the 
survey have not been published, these comments asserted that no 
pathogenic bacteria were found in the cider samples evaluated by the 
agency.
    These comments refer to a 1997 assignment in which FDA inspected 
fresh unpasteurized apple cider operations and collected in-line 
product for microbiological analysis at 237 establishments in 32 
States. Although FDA has not issued its summary of results from this 
assignment, the agency notes that this assignment generated 
microbiological data at several stages of operation in these facilities 
including the incoming apples, wash water, apples taken after washing 
but before processing, and finished cider both preserved and 
unpreserved. The microbiological analyses at these various steps were 
for pathogens such as E. coli 0157:H7 and Salmonella sp. and also for 
fecal coliforms and generic E. coli, which are not foodborne pathogens, 
but are used as indicators of fecal contamination that could be a 
potential source for contamination by pathogens. It was the agency's 
intent to consider all of the data generated to assess microbiological 
safety factors for cider. The agency does not consider it appropriate 
to focus on any one aspect of its findings, i.e., the lack of any 
positive finding for pathogens in finished product, for drawing 
conclusions about the microbiological safety of cider.
    This assignment did not result in the detection of any pathogens in 
a finished cider product intended to be sold to the public. However, 
FDA's preliminary findings from this assignment show that one firm's 
incoming apples tested positive for Salmonella sp. indicating that 
microbial hazards that necessitate effective control measures are 
reasonably likely to occur on incoming apples. Moreover, FDA's 
preliminary findings show that fecal coliforms and E. coli were found 
in the wash water used at several firms, indicating that the water is 
of poor quality. In addition a small number of finished cider products 
tested positive for fecal coliforms and generic E. coli was found in 14 
percent of the finished product samples.
    These findings further support the agency's action here in that 
they establish that risk factors such as pathogenic bacteria and fecal 
coliforms can exist in cider processing operations and could give rise 
to microbiological safety hazards in finished cider products. The 
findings of this FDA assignment clearly do not support the comment's 
contention that the health risk posed by cider is insufficient to 
justify a warning label.
    4. Several of the comments that opposed warning statements on juice 
products contended that they are unnecessary. Two of these comments 
asserted that FDA should educate the consumer that the problem is not 
the juice, but rather, the fact that the juice is contaminated with 
animal feces and not properly processed.
    FDA does not agree with this comment to the extent that it asserts 
that a warning statement should not be part of the Federal response to 
the problem of contaminated juice. Juice products that contain 
pathogenic microorganisms can be a vehicle for foodborne illness 
regardless of whether the microbial contamination arises from the 
source fruit or vegetable or from insanitation during manufacture. 
FDA's HACCP proposal is designed to ensure the safe and sanitary 
processing of juice. The warning statement, which is itself a form of 
education, is required only for those juices that have not been 
processed to achieve the pathogen reduction performance standard. 
Consumers, particularly those at greatest risk, need to know that 
untreated juice may contain harmful bacteria that could cause serious 
illness so that they may make informed choices. FDA expects that the 
warning statement will reduce the risk of illness because some of the 
at-risk consumers likely will choose not to expose themselves to the 
hazard.

B. Juice Products Versus Other Food Products That May Contain Pathogens

    5. Several comments claimed that the agency's actions were 
discriminatory in nature and not proportional to the health hazard 
posed by unpasteurized juices. These comments questioned why other food 
products associated with recent foodborne illnesses are not required to 
bear warning statements (i.e., fruits, berries, eggs, melons, poultry, 
hamburgers, meat products, seafood, etc.).
    The agency disagrees with these comments. Juice products 
historically have been consumed by individuals without treatment to 
control pathogenic microorganisms. In addition, the presence of some of 
the pathogens (i.e., E. coli O157:H7 and Crytosporidium)

[[Page 37033]]

that have been responsible for recent outbreaks of foodborne illnesses 
associated with untreated juice products is a relatively new 
phenomenon. Therefore, consumers do not associate such pathogens, and 
the risk that they present, with the consumption of untreated juice. 
Accordingly, in the juice labeling proposal, the agency tentatively 
concluded that a juice warning statement is needed to protect the 
public health because consumers are unaware of the nature and magnitude 
of the hazard.
    In contrast, other mechanisms are in place to reduce the risk of 
foodborne illness from consumption of many of the foods discussed in 
the comments. First, consumers have some awareness that meat and 
poultry products have the potential to contain harmful microorganisms; 
also, these foods ordinarily are cooked prior to consumption. Moreover, 
meat and poultry products that are regulated by the U.S. Department of 
Agriculture's Food Safety and Inspection Service (USDA/FSIS) are 
subject to that agency's HACCP regulations. In addition, regulations 
issued by USDA/FSIS require safe handling instructions on raw meat and 
poultry products advising consumers to thoroughly cook the products.
    Other products mentioned in the comments are regulated with the 
goal of ensuring microbial safety. For example, seafood products are 
now required to comply with FDA's HACCP program for seafood products. 
Recently, FDA issued draft guidelines for good manufacturing practices 
and good agricultural practices regarding raw agricultural commodities 
(63 FR 18029, April 13, 1998). In addition, the agency recently 
requested public comment on its plan to implement a comprehensive 
``farm to table'' strategy to decrease food safety risks associated 
with shell eggs (63 FR 27502, May 19, 1998).
    Thus, FDA's requirement for a warning statement on untreated juice 
products has a rational foundation and is part of a comprehensive 
approach to solve a larger problem. The agency therefore finds no merit 
in the assertion that the agency's proposed actions are discriminatory 
when compared to the regulatory approaches that are already in place or 
that are being considered for other food products that have been 
associated with foodborne illness.

C. Regulatory Approach

    6. Some comments asserted that the purpose of the juice labeling 
rule is to force manufacturers to pasteurize juices, particularly apple 
cider. Comments from some cider manufacturers contended that their 
customers don't want pasteurized cider, and a few of these comments 
contended that pasteurizing cider converts the product to apple juice.
    While pasteurization is an effective and proven mechanism that has 
been shown to satisfy the pathogen reduction standard, it is not the 
only mechanism capable of achieving a 5-log reduction. As discussed in 
the HACCP proposal, the pathogen reduction performance standard is a 
performance-based, rather than process-based, standard. Thus, as 
addressed in response to comment 35, mechanisms other than 
pasteurization may be used to satisfy the pathogen reduction 
performance standard. Thus, FDA disagrees with these comments.
    7. Some of the comments argued that a warning statement will not 
reduce the hazards associated with unpasteurized juice or make a safer 
juice industry.
    The agency agrees that a warning statement will not directly reduce 
the hazards associated with juice products. However, the purpose of the 
warning statement is to provide consumers with information regarding 
the potential hazards associated with untreated juice and thereby to 
allow consumers, including those most vulnerable, to make informed 
choices. Thus, FDA expects that the warning statement will reduce the 
risk of illness because some of the at-risk consumers likely will 
choose not to expose themselves to the hazard.
    The agency also acknowledges that warning statements will not 
directly make a safer juice industry. Indeed, it is for that very 
reason that the agency concurrently proposed a HACCP program to reduce 
or eliminate the hazards associated with juice products.
    8. One comment contended that warning labels will encourage 
producers to ignore good manufacturing practices (GMP's) because of 
their belief that the presence of the warning statement will remove the 
producer's liability for the product.
    The agency rejects the comment. The presence of the warning 
statement does not remove the manufacturers' responsibility of adhering 
to GMP's or his liability for the finished product. Regardless of this 
final rule, a juice product that is found to contain harmful bacteria 
would be adulterated under section 402(a)(1) of the act (21 U.S.C. 
342(a)(1)) and thus, illegal.
    9. One comment asserted that the requirement for a warning 
statement is contrary to agency policy of disallowing adulterated 
products to be sold. This comment also asked whether a juice product 
that bears the warning statement would be subject to recall if it were 
found to be contaminated with pathogenic microorganisms.
    The evidence available at this time documents that there is a risk 
of foodborne illness from consumption of untreated juice. The agency 
does not contend, nor does the validity of the juice labeling proposal 
require, a showing that all unpasteurized juice is adulterated. Thus, 
FDA disagrees that requiring a warning statement essentially permits 
adulterated food to be marketed. As noted, the warning statement is 
intended to provide consumers important information not otherwise 
available on the label or in labeling (namely, that a risk of serious 
illness exists if the products are consumed by certain groups of the 
population.) Upon the effective date of this final rule, a covered 
product that does not comply with the labeling requirement would be 
misbranded under sections 201(n) and 403(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)(1)). 
Regardless of this final rule, a juice product that is found to contain 
harmful bacteria would be adulterated under section 402(a)(1) of the 
act (21 U.S.C. 342(a)(1)) and thus, illegal. This adulterated status 
would persist regardless of whether product labeling included the 
warning statement.
    Similarly, although FDA has no express authority to mandate the 
recall of adulterated foods, FDA fully expects that any manufacturer 
who has distributed an adulterated juice product would voluntarily 
recall that product as soon as a microbial contamination problem was 
identified.
    10. Several comments suggested that FDA should implement HACCP 
requirements immediately rather than require warning labels on 
untreated juice products. Other comments supported the use of a warning 
statement on food products only as an interim measure until the agency 
establishes a more comprehensive solution to the problem of microbial 
contamination in juice.
    In each of the recent agency documents regarding juice (i.e., the 
notice of intent (62 FR 45593 at 45594), the juice labeling proposal 
(63 FR 20486 at 20487), and the HACCP proposal (63 FR 20450 at 20457)), 
FDA tentatively concluded that the implementation of its proposed HACCP 
program is the most effective long-term measure for controlling 
pathogens and other safety concerns related to the production and 
distribution of juice products. As discussed in the juice labeling 
proposal, warning statements are intended to serve as a short-term 
alternative for almost all untreated juice products until

[[Page 37034]]

HACCP programs that ensure that the juice will be processed in a manner 
that meets the pathogen reduction performance standard can be developed 
and implemented by the juice industry. Once such HACCP programs are in 
place, the agency does not presently foresee the need for a warning 
statement on products processed in a manner that meets the pathogen 
reduction performance standard, and this final rule is consistent with 
that view. However, the agency's proposed HACCP regulations would not 
cover: (1) The operation of a retail establishment; or (2) the 
operation of a very small business that is also a retail establishment 
and that makes juice on its premises, provided that the establishment's 
total sales of juice and juice products do not exceed 40,000 gallons 
per year, and provided that the establishment sells such juice directly 
to consumers or other retail establishments. Thus, it is likely that 
not all juice products will be produced under a HACCP system. In 
addition, a program as comprehensive as the agency's proposed HACCP 
program requires more time to implement than a labeling requirement. 
This is particularly true in light of the provision in the juice 
labeling proposal that the warning statement requirement may be met, in 
the short term, by labeling (i.e., a sign or placard that is displayed 
at the point of sale) rather than by application of the warning 
statement to the product label (proposed Sec. 101.17(g)(3)). FDA 
believes that the warning statement, together with HACCP, makes the 
agency's response to this problem a comprehensive solution. Therefore, 
the agency is making no changes to its regulatory approach in response 
to these comments.
    11. Several comments expressed the opinion that use of the terms 
``pasteurized'' or ``unpasteurized'' alone is sufficient to inform 
consumers of potential risks associated with consumption of juice 
products. Some of these comments maintained that use of the term 
``fresh, unpasteurized'' would more clearly indicate that the juice is 
unprocessed.
    Other comments agreed with the agency's rationale in the juice 
labeling proposal that a warning statement that merely characterizes 
juice as ``pasteurized'' or ``unpasteurized'', without also including 
the information about the nature and magnitude of the hazard, would be 
incomplete. Some comments noted that unpasteurized juice may have a 
reputation among many consumers for being a particularly fresh and 
healthful food. These comments contended that it is important to ensure 
that product labeling meets both the needs of consumers who are at risk 
of serious illness as well as the needs of consumers who prefer to 
purchase untreated juice because they perceive such products to be 
healthful.
    In the juice labeling proposal, the agency fully discussed its 
rationale for tentatively concluding that not providing information 
about the nature and magnitude of the hazard presented by untreated 
juices would constitute misbranding of the product. The agency is 
concerned that some consumers do not know the significance of 
pasteurization and, therefore, would not be able to make an informed 
decision on whether to purchase and consume the products. In focus 
group research, FDA determined that, while most participants had a good 
understanding of what pasteurization was, a significant number of the 
participants did not. The agency acknowledged that indicating whether a 
product is ``pasteurized'' or ``unpasteurized'' may be useful to 
consumers who are seeking to purchase either type product. However, FDA 
tentatively concluded that use of the terms ``pasteurized'' or 
``unpasteurized,'' alone, informs the consumer on the type of 
treatment, or lack of treatment, that a product has received and would 
not give consumers information about the risks presented by untreated 
juices. In reaching this tentative conclusion, the agency considered 
comments to the notice of intent that expressed opinions similar to the 
comments subsequently submitted to the juice labeling proposal. The 
latter comments provided no new information to provide a basis for FDA 
to change that tentative conclusion. Therefore, FDA is not adopting the 
suggested approach that, instead of the warning statement requirement, 
the agency require all juice products to be labeled as ``pasteurized'' 
or ``unpasteurized.'' Nonetheless, as a general matter, statements that 
are truthful and not misleading are always permitted under the act. 
Thus, manufacturers who choose to make a statement, on the product 
label or in labeling, that describes a juice product as ``pasteurized'' 
or ``unpasteurized'' may do so as long as the statement is factually 
accurate and is not presented in a manner that would cause the 
statement to be misleading.
    12. One comment questioned FDA's proposal to require that untreated 
juice products bear a warning statement in light of the fact that the 
agency does not require foods containing known allergens, such as 
peanuts, to bear a warning statement.
    FDA disagrees with the suggestion contained in this comment. The 
purpose of a warning statement is to provide consumers with important 
information that did not otherwise appear on the product label or in 
labeling. FDA recognizes that many foods contain substances (e.g., 
peanuts) that cause an allergic response in those persons sensitive to 
the substance. Current food labeling regulations require, in virtually 
all cases, a complete listing in the ingredient statement of all of the 
ingredients of the food. Consequently, the label of foods containing 
such substances already provides sufficient information to allow 
sensitive individuals to avoid food products that contain substances to 
which they are allergic. Thus, as a general rule, a statement warning 
about the potential for an allergic reaction is not needed to protect 
the public health. With untreated juice, there is no other disclosure 
regarding the potential presence of pathogens in unprocessed juice, 
and, due to the relatively recent nature of such risk, sensitive 
individuals (which may be as much as 25 percent of the general 
population) (Ref. 2) are not aware of the hazard.
    13. Some comments contended that warning statements are not 
generally effective at preventing the targeted behavior, pointing to 
the failure of warnings on other commodities, such as cigarettes and 
alcohol, to have the desired effect. Other comments considered it 
likely that the proposed warning statements would be effective because 
the risks associated with consuming untreated juice are not widely 
known or understood and consumers would use the new information to make 
informed choices that they were unable to make without the new 
information. Some comments advocated the use of brochures or pamphlets 
outlining the risks associated with consumption of untreated juices as 
an alternative to a warning statement.
    In its focus group research on juice labeling, and in recent survey 
results (Ref. 3), FDA confirmed that consumers are largely unaware of 
the potential hazards of consuming untreated juice. Thus, the proposed 
warning statement contains information that is new to consumers. This 
fact separates the proposed warning statement from warning statements 
on other commodities such as alcohol or tobacco where the information 
contained in the statement is already widely known and familiar to most 
people. Research on warning statement effectiveness has identified the 
lack of new information in the warning statement as the principal 
reason that warning

[[Page 37035]]

statements are ineffective (Ref. 4). Participants in the focus groups 
said that the information about the risks of untreated juice was new 
and would have a substantial impact on their juice product choices.
    The agency agrees that the effectiveness of the warning statement 
would be enhanced by an educational campaign that provides consumers 
with materials such as brochures or pamphlets containing information 
giving a fuller context to the hazard. FDA is continuing to provide 
educational information to consumers concerning juice. However, the FDA 
focus group participants strongly expressed a need for product specific 
information that clearly identified a product, on its label, as 
``unpasteurized'' and that described the nature of the hazard. The 
reasons given by the focus group participants were that this was new 
information to them and they considered such information necessary to 
make informed choices. Educational materials could be an adjunct to a 
warning statement, and the agency encourages firms to develop and 
provide them where possible. However, FDA believes that the warning 
statement required by this final rule is necessary to adequately and 
efficiently communicate to consumers the risks presented by unprocessed 
juice. Therefore, FDA declines the suggestion in the comments that 
educational materials such as brochures or pamphlets should substitute 
for the warning statement.
    14. Several of the comments asserted that, in general, a warning 
statement would remind consumers of products such as cigarettes, which 
are well known to be a health hazard for the general population, or 
alcoholic beverages, which are well known to be harmful to the general 
population when consumed in excess or to a developing fetus when 
consumed by a pregnant woman. In essence, these comments contended that 
a warning statement on a juice product, which consumers perceive as 
healthful, is inappropriate because it casts that product in the same 
light as products that are a known health hazard.
    FDA agrees that products such as cigarettes and alcohol have 
characteristics that present a known health hazard to the general 
population. However, these products also are subject to regulatory 
control mechanisms, other than warning statements, commensurate with 
their risk. Relative risk aside, FDA believes that the level of risk 
associated with untreated juice justifies the requirement for a warning 
statement. The focus group research reflects the importance of this 
information in that many focus group participants said that the risk 
information would have a substantial impact on their juice product 
selection. Even participants who said that they would continue to drink 
untreated juice products because of the perceived benefits also said 
that the information would influence whether they would give such 
products to their children.
    15. Some comments maintained that a warning statement on covered 
juice products would be tantamount to stating that the products contain 
pathogens.
    FDA does not agree with these comments. The agency's warning 
statement is carefully worded to state that the products in question 
``may contain'' harmful bacteria. This statement is factually accurate.
    16. Some comments pointed out that the National Advisory Committee 
on Microbiological Criteria for Foods (NACMCF) did not support warning 
statements.
    The agency disagrees with the comments' view that NACMCF did not 
support a warning statement for juice products. In fact, NACMCF stated 
that it lacked sufficient data to evaluate the effectiveness of 
labeling statements as safety interventions or to help consumers make 
informed choices. Therefore, NACMCF declined to endorse labeling as an 
interim safety measure and instead endorsed implementation of a 
comprehensive HACCP program as a preventive system of hazard control to 
ensure the safe and sanitary processing of fruit and vegetable juices 
and juice products. As already discussed, the agency has likewise 
tentatively concluded in the HACCP proposal that a HACCP program for 
juice products is the best long-term strategy for public health 
protection; the juice warning statement is intended largely as an 
interim measure to inform consumers about the potential risk associated 
with untreated juice products until the application of HACCP principles 
increases the safety of juice products. Thus, FDA is making no changes 
to its regulatory approach in response to these comments.
    17. Several comments questioned the precedent set by FDA in 
applying a warning label to fresh juice. The comments noted that 
requiring this warning label establishes a regulatory trend which, if 
continued, would result in virtually all foods carrying warnings. 
Having too many warnings on food would make the warnings meaningless.
    FDA agrees that too many warning labels on foods could result in 
loss of consumer credibility and effectiveness. However, the agency 
does not agree that it is establishing a trend toward too many warning 
labels. The agency has used the authority under sections 201(n) and 
403(a)(1) of the act only rarely to require warnings or other 
cautionary label statements. FDA cannot require labeling unless the 
need for it meets the statutory criteria of being necessary either to 
clarify existing label statements or because of consequences that may 
result from customary or usual use of the food.
    18. A few comments cited an agency memorandum that is part of the 
administrative record of the juice labeling proposal (Ref. 5). These 
comments interpreted the memorandum to reflect the agency's opinion 
that warning statements are an ineffective method for communicating 
with consumers or that the agency does not have data that show that 
warning statements are effective in convincing target populations to 
avoid a particular substance.
    The agency does not agree with these comments. The key point of the 
memorandum is that warning statements need to be evaluated in consumer 
testing because it is difficult for experts to anticipate consumers' 
assumptions and prior beliefs about a product and its potential 
hazards. The memorandum identified communication problems encountered 
with a variety of proposed warning statements and concluded that the 
remedy to these kinds of potential problems is to subject proposed 
warning statements to consumer testing to determine if they communicate 
as intended. The memorandum underscored the need to test proposed 
options for the juice warning statement, and the agency did so, with 
the results summarized in a report that is in the administrative record 
of this rulemaking. This consumer testing helped the agency to identify 
a statement that can inform consumers about a previously unrecognized 
hazard without being overly alarming.
    In addition, these comments incorrectly suggest that FDA has no 
basis for believing that warning statements can be effective. In fact, 
the memorandum focuses on the communication effectiveness of warning 
statements rather than the broader policy question of how well warning 
statements work in the marketplace. The intent of warning statements is 
to provide consumers with information necessary to make informed 
choices. Qualitative research suggests that warning statements are 
effective in alerting vulnerable populations to potential risks but 
that consumers' ultimate decisions are based on a variety

[[Page 37036]]

of considerations, including their prior experiences, personal 
preferences, the tradeoffs they are willing to make, and their 
awareness of particular risks gained by reading warning statements.
    Because these comments misinterpret FDA's position, the agency is 
making no changes to its regulatory approach in response to these 
comments.
    19. Some comments expressed the opinion that FDA acted contrary to 
public relations research theory by developing script guidelines used 
by focus group moderators. This comment asserted that, as a result, the 
focus group results were biased by FDA.
    FDA disagrees with the assumption underlying this claim of bias--
i.e., that the moderator of the focus groups was given a script. The 
agency has extensive experience conducting focus group studies, which 
are a qualitative type of research that generates discussion on the 
issues in question, allowing for many points of view and differing 
levels of interest and knowledge. The agency's goals in conducting 
focus group research are to understand how consumers think about the 
subject issues, to see how they react to language that the agency and 
other interested parties have suggested to convey health-related 
messages, and to uncover erroneous beliefs and assumptions about how 
consumers will think and respond to proposed communications. In FDA-
sponsored focus group research, the moderator is a professionally 
trained neutral party, who is briefed on the subject matter of the 
study to the extent necessary to lead the discussion. The moderator 
works closely with FDA to ensure that the materials and questions meet 
the highest standards for the conduct of qualitative research. The 
moderator's guide is a primer to help the moderator cover the topics of 
interest rather than a ``script.'' Accordingly, the agency finds no 
merit in the assertion in the comment that the focus group studies were 
biased.
    20. Some comments contended that a warning statement could have a 
potentially negative impact on consumers by discouraging the 
consumption of all fruit and vegetable juice products, regardless of 
whether the products had been processed to control pathogenic 
microorganisms. Some of these comments expressed the opinion that this 
negative impact could potentially carry over to other healthful 
products such as fruits and vegetables.
    These comments provided no data or other information to 
substantiate the assertion that a warning statement on untreated juice 
products will result in a decreased consumption of all juice products 
or of fruits and vegetables generally. Nonetheless, FDA will seek to 
minimize any remote possibility that consumers' reaction to the juice 
warning statement would be to avoid all juice products or to avoid 
fresh fruits and vegetables by emphasizing in the agency's ongoing 
consumer education initiative that: (1) Most juice products are 
processed to control pathogenic microorganisms and therefore are safe; 
(2) the warning statement has a limited and targeted scope based on the 
distinctive characteristics of untreated juice products; and (3) the 
warning statement will be a reliable cue to tell whether a product has 
or has not been processed to control pathogenic microorganisms. 
Accordingly, FDA concludes that the concerns raised in these comments 
provide no basis to alter the agency's regulatory approach.
    In the juice labeling proposal, FDA acknowledged that it would take 
time for manufacturers to make label changes and deplete existing label 
inventories. Accordingly, FDA proposed that, as a temporary alternative 
to providing the information on the label, firms could provide the 
warning statement in labeling, e.g., signs or placards, at the point of 
purchase.\2\ Under proposed Sec. 101.17(g)(3)(i), manufacturers could 
provide the warning statement in labeling until January 1, 2000, the 
next uniform compliance date for other food labeling changes. To 
relieve the burden on small businesses, proposed Sec. 101.17(g)(3)(ii) 
provided that small businesses could provide the warning statement in 
labeling until January 1, 2001.
---------------------------------------------------------------------------

    \2\ The term ``label'' means any written, printed, or graphic 
matter on the immediate container of an article (section 201(k) of 
the act). The term ``labeling'' means all labels and other written, 
printed, or graphic matter either on any article or its containers 
or wrappers, or accompanying such article (section 201(m) of the 
act). Thus, signs and placards that appear at point-of-sale are a 
type of labeling.
---------------------------------------------------------------------------

    21. Some comments contended that consumers may not notice the 
warning in a sign or placard at all. Other comments expressed concern 
that the message would not be apparent to the consumer when the product 
was ready to be consumed or would not be apparent to other members of 
the household who did not have the opportunity to see the sign at the 
point of purchase.
    Other comments expressed concern that consumers would not correctly 
link the warning message with the appropriate juice product. The 
comments stated that, for example, a sign may be placed outside a 
refrigerator that contains both pasteurized and untreated juice 
products and the label of many juice products does not inform the 
consumer as to whether the product has been pasteurized. As a 
consequence, consumers could choose not to purchase any product at all.
    The majority of comments that addressed the issue of labeling as an 
interim means of compliance with the warning statement requirement 
opposed the length of time that labeling would be allowed. Some 
comments pointed out that, if the urgency of the public health concern 
justified the shortening of the comment period, then FDA should not 
allow an extended time for the warning statement to appear on the 
label. Other comments contended that FDA's notice of intent provided 
ample notice to firms to prepare for label changes because FDA urged 
voluntary compliance at that time.
    Some of these comments also opposed the additional time allowed for 
small businesses to place the warning statement on the labels of their 
products. The comments asserted that the public health concern existed 
whether or not the firm was small.
    FDA finds merit in these comments. The agency agrees that placards 
and signs may be less effective than package labels for the purpose of 
communicating product-specific information to consumers. FDA's 
experience with the voluntary labeling of fresh fruits and vegetables 
in supermarkets also indicates that this is the case. While the agency 
found high levels of voluntary nutrition labeling in supermarkets, 
consumer research showed that only a small proportion of consumers 
reported that they had seen this labeling in stores (Ref. 6).
    However, as a practical matter, producers of unpasteurized juice 
need time to modify their labels to include the warning statement. In 
response to the concerns about the effectiveness of signs and placards, 
FDA is reducing the length of time that it will permit manufacturers to 
provide the warning statement in labeling. The label change being 
required is not complex. FDA believes that small business will not 
experience more difficulty than large businesses in making the change. 
Therefore, FDA is giving small and large businesses the same amount of 
time to make the change. Accordingly, the effective date of this final 
rule applies equally to all manufacturers of packaged juices, 
regardless of size. Thus, this final rule (Sec. 101.17(g)(4)) provides 
that, except for unpackaged juices (which have no label), the required 
warning statement may be provided in labeling at point of purchase, 
until 1 year from the date of compliance with the final rule. In 
essence, this provision provides

[[Page 37037]]

manufacturers the alternative of using labeling for a single juice 
season. This flexibility will postpone by a juice season a 
manufacturer's need to revise and reprint labels that would be affixed 
to packaged untreated juice products.\3\ During this interim period, 
the agency's ongoing food safety education campaign will help consumers 
to look for, and understand, juice labeling posted at the point of 
purchase.
---------------------------------------------------------------------------

    \3\ As discussed in section VI of this document, this final rule 
establishes a compliance date for apple juice and apple cider that 
will closely coincide with the 1998 fresh apple juice season. This 
final rule also establishes a compliance date for juice products 
other than apple juice and apple cider that will closely coincide 
with the 1998 fresh citrus juice season.
---------------------------------------------------------------------------

    The agency acknowledges that there are some costs associated with 
this revision to the proposed rule. FDA's analysis of the economic 
impact of this revision is discussed in section VIII of this document.
    22. Some comments suggested that a more appropriate interim measure 
than the use of signs or placards would be the application of the 
warning statement to the product label via stickers. One comment 
estimated the cost of placing stickers with the warning statement on 
packaged containers. For 1,000 bottles, the comment estimated the cost 
to be $28.25. The estimate in the comment was based on several 
assumptions. First, the time and cost to design the sticker is 
negligible. Second, the total cost to pay the bottle supplier to apply 
the 1,000 labels is 70 cents. Third, there are no printing charges 
beyond the basic per unit cost of the label.
    FDA acknowledges that firms could comply with the warning statement 
requirement through the use of stickers. Many manufacturers may find it 
more convenient to apply the warning statement to packaged product by 
means of stickers than to provide signs or placards to all retailers 
who sell their product.
    However, there are costs associated with using stickers to revise a 
label. FDA disagrees with the estimate included in the comment because 
FDA disagrees with the underlying assumptions presented in the comment. 
First, there are always costs of specifying to the printer what the 
sticker will say and the way it will look, as well as costs of finding 
the printer to produce the stickers. The agency estimates that these 
administrative costs are $100. Second, it is not feasible to have 
bottle suppliers place labels on bottles this close to the beginning of 
the juice seasons. As some comments noted, bottles and labels for this 
season are already in inventory and waiting for the beginning of 
processing. The agency estimates the cost of applying the labels by 
multiplying the average rural hourly cost of labor ($13.00) by the 
number of hours it would take to label 10,000 gallon size packages (the 
average size of plant that will be using the warning statement) and the 
cost of extra equipment needed to apply this volume of labels. The 
agency estimates this cost to be $600. Third, printers levy one time 
charges for set-up in addition to the basic per unit cost of labels. 
The agency has estimated total printing costs for a 10,000 gallon 
operation to be $250. Thus, the agency's estimate of the cost of 
achieving compliance within 60 days through use of stickers is 
approximately $1,000. This is in contrast to the $100 agency estimate 
of the cost of achieving compliance through use of signs or placards. 
Thus, while FDA considers stickers an acceptable means of revising a 
label, in light of the cost differential between labels and placards, 
the agency is not persuaded that it should mandate the use of labels 
with stickers for the 1998 juice season. Accordingly, FDA is making no 
additional changes to its provisions for interim compliance with the 
warning statement requirement through labeling in response to these 
comments.
    23. Some comments that objected to allowing juice product 
manufacturers to use labeling while they change labels noted that the 
USDA requirement for safe handling instructions on raw meat and 
poultry, which was issued in response to a similar public health 
concern, was effective 60 days after its publication, with no temporary 
allowance for labeling.
    FDA acknowledges that the final regulation requiring safe handling 
label statements on meat and poultry products (59 FR 14528, March 28, 
1994) became effective for comminuted products 60 days after 
publication, with no temporary allowance for labeling. However, the 
comment failed to fully describe the circumstances surrounding the FSIS 
rulemaking. On August 16, 1993 (58 FR 43478), FSIS published an interim 
final rule requiring the safe handling statements, with opportunity for 
comment. On October 12, 1993 (58 FR 52856), FSIS published a final rule 
requiring the safe handling statements, with an immediate effective 
date. On November 4, 1993 (58 FR 58922), FSIS withdrew the October 12, 
1993, rule as a result of litigation and reproposed its regulations 
requiring safe handling instructions. Finally, FSIS published the final 
rule cited by the comments, with an effective date of 60 days--i.e., 
May 27, 1994--for comminuted products.\4\ Because the safe handling 
statements did not change between October 12, 1993, and March 28, 1994, 
the meat and poultry industry had approximately seven and one half 
months to prepare new labels. Moreover, in its rulemaking and 
subsequent FSIS Directives, FSIS allowed the use of any labels that 
bore the safe handling instructions proposed in August 1993, until the 
inventory was depleted.
---------------------------------------------------------------------------

    \4\ The effective date for all other meat and poultry products 
was July 6, 1994.
---------------------------------------------------------------------------

    Given these circumstances, the alternative provided 
bySec. 101.17(g)(4) that manufacturers may comply with the warning 
statement requirement through labeling is, as a practical matter, 
similar to the added time that manufacturers received to comply with 
the FSIS rule requiring safe handling statements as a result of FSIS' 
withdrawal of the October 12, 1993, rule. The agency believes that 
these comments require no changes to the provisions of 
Sec. 101.17(g)(4).

III. Covered Products

A. Unpackaged Juices

    In the juice labeling proposal, FDA proposed to require a warning 
statement on packaged juice products not processed to prevent, reduce, 
or eliminate pathogens. FDA specifically noted that the agency's 
proposal excluded unpackaged juice sold for immediate consumption 
(e.g., juice sold by the glass in restaurants, grocery stores or other 
food establishments). Comments from the restaurant industry supported 
the exclusion from the warning statement requirement of unpackaged 
juice sold for immediate consumption. Other comments requested that the 
warning statement requirement not exclude unpackaged juice products. In 
general, these comments asserted that unpackaged fresh juices pose the 
same risk as fresh juices sold in containers.
    24. A few comments pointed out that unpackaged juices have 
accounted for some of the cases of serious illness that have been 
associated with consumption of fresh cider. Another comment expressed 
the view that contamination of fresh juices may be more likely in 
retail establishments that prepare unpackaged juices than in 
manufacturing facilities that prepare packaged juices because personnel 
who work in retail establishments may lack relevant training that 
ordinarily is provided to personnel who work in manufacturing 
facilities. Other comments contended that the agency's proposal that 
the warning statement

[[Page 37038]]

requirement apply only to packaged juices would create consumer 
confusion. For example, consumers would be unable to distinguish, in 
all circumstances, between unlabeled juice that had been processed to 
control pathogenic microorganisms and unlabeled juice that had not been 
so processed. Most of these comments asserted that the warning 
statement requirement should apply equally to packaged and to 
unpackaged juices.
    As part of its decision to propose to require a warning label on 
untreated juice, FDA considered, among other things, the issues raised 
in these comments, and tentatively concluded not to specifically 
require the labeling of unpackaged juice. As stated in the juice 
labeling proposal, this approach is consistent with the agency's food 
labeling regulations which do not apply to food distributed to 
consumers in unpackaged form unless specifically noted in the 
regulations (63 FR 20486 at 20487). Because these comments did not 
provide any information that the agency had not considered at the time 
it published the proposal, the agency is maintaining its position to 
not include unpackaged juice in the scope of the warning labeling 
requirement.

B. Apple Juice Products versus Non-Apple Juice Products

    Several comments, almost exclusively from citrus juice interests, 
asserted that the labeling requirement should apply only to apple juice 
and apple juice products and should not apply uniformly to juices of 
other fruits, especially citrus fruits, or to vegetable juices. The 
comments provided a number of reasons as justification for a 
differential application of the warning statement requirements. FDA 
discusses these specific comments, and the agency's response, below.
    25. Some comments claimed that the extraction methods for citrus 
juices justify excluding such juices from the warning statement 
requirement. Specifically, comments asserted that the extraction of 
apple juice necessarily involves contact of the expressed juice with a 
substantial portion of the peel surface for an extended period of time, 
during which pathogenic organisms on the peel can pass into the juice. 
The comments asserted that, in contrast, the extraction of citrus juice 
involves contact of the expressed juice with a small fraction of the 
peel surface for a period of time much shorter than that for the 
extraction of apple juice, thereby limiting the opportunities for 
microorganisms on the peel to pass into the juice. In addition, one 
comment stated that the smooth surface and disposable outer peel of 
citrus fruit make it easier to sanitize and prepare citrus fruit for 
juice extraction. This comment also stated that drops (i.e., fruit that 
has fallen to the ground) are not used in the fresh citrus juice 
industry, the extraction method typically used allows less than 2 
percent of the presanitized peel surface to come into contact with the 
juice, and the interior of the citrus fruit is sterile.
    FDA does not agree that the described differences in juice 
extraction methods, with concomitant differences in peel/juice 
exposure, justify the selective application of the warning statement 
requirement. The agency acknowledges that the physical characteristics 
of citrus fruits may help to facilitate safe and sanitary citrus juice 
extraction operations. However, the comments did not include sufficient 
data to demonstrate that these factors are sufficient to ensure the 
safe and sanitary processing of citrus juices. Moreover, the 
significance of the peel-juice contact as a source of pathogens that 
may be present in the juice depends on the microbial load on the peel; 
that initial microbial load may vary with preextraction conditions. In 
addition, the comments provided no substantive information to establish 
the rate of transfer of pathogens from peel to expressed juice; thus, a 
minimum timeframe for contamination remains unknown.
    26. One comment asserted that citrus juices should be exempt from 
the warning statement requirement because the citrus industry is 
rapidly adopting the following practices to achieve, at a minimum, a 3-
log reduction in microbial count: (1) A grading line to remove 
compromised fruit; (2) rinsing stations; (3) washing fruit with 
commercial cleaning agent and brush scrubbing; (4) application of 
sanitizer; (5) heat dryers; (6) extraction equipment that minimizes the 
amount of peel that contacts the juice; and (7) imposition of good 
manufacturing practices (GMP's) set out in part 110 (21 CFR part 110).
     The agency agrees that the described operations are major pathogen 
reduction steps and would likely result in a reduction of pathogen 
levels. Indeed, in the HACCP proposal, the agency acknowledged that it 
is possible that whole oranges with an intact skin may be processed so 
that pathogens on the surface of the fruit are destroyed (63 FR 20450 
at 20478). However, once again, the comments provided no data or other 
substantive information to verify that such operations have been 
adopted industry-wide. In addition, the comments claimed only that 
these processing practices allowed the citrus industry to achieve, at a 
minimum, a 3-log reduction in microbial count. As noted, both in the 
proposed rule (proposed Sec. 101.17(g)(6)) and in this final rule 
(Sec. 101.17(g)(7)), the pathogen reduction performance standard would 
require a 5-log reduction in pathogens. Moreover, consistent with 
customary scientific practices, the method that produces the 5-log 
reduction should be validated. Thus, the comments do not establish that 
the citrus juice industry is universally or automatically meeting the 
pathogen reduction standard established in this final rule. 
Accordingly, the comments did not provide a basis for the agency to 
exclude citrus juices from the warning statement requirement. However, 
as discussed later in this document (see comment 42), the agency 
believes that citrus processors should be able to achieve and validate 
a 5-log reduction.
    27. Some comments asserted that the chemical composition of certain 
fruits and vegetables justifies differential application of the warning 
statement requirement.
    The agency recognizes that various fruits and vegetables differ in 
their indigenous chemical composition. In fact, even within a variety 
of a particular fruit or vegetable, there can be some variation in 
composition depending on growing conditions. However, the comments 
provided no data to show how chemical composition of a juice bears on 
its safety. The comments also provided no data to show how chemical 
attributes that are unique to citrus products will ensure the safety of 
fresh citrus juices. Therefore, FDA does not agree that differences in 
chemical composition of various fruits and vegetables and their juices 
justify the comments' request that certain juices not be subject to the 
warning statement requirement.
    28. Finally, some comments asserted that differences in the degree 
to which citrus juices have been associated with illness outbreaks 
justify exempting citrus juices from the warning statement requirement.
    The agency disagrees. A 1997 study of recombinant E. coli 0157:H7 
growth in apple juice and orange juice indicated that citrus juices 
provide an environment for growth of this microorganism (Ref. 9). In 
the study, there was only a small decline in numbers of E. coli 0157:H7 
inoculated into orange juice over a 24-day period at refrigeration 
temperatures. The fact that E. coli 0157:H7 can survive in citrus juice 
and the fact that human illnesses from other pathogens have been traced 
epidemiologically to citrus juice demonstrates that, if contaminated,

[[Page 37039]]

these juices have potential to cause human illness. Therefore, the 
agency finds no basis in the comments to conclude that the level of 
association of citrus juices with illnesses of public health 
significance is so low as to justify their exclusion from the warning 
statement requirement.
    29. A few comments questioned whether the warning statement 
requirement should apply to carrot juice because there have been no 
outbreaks of illness linked to this product.
    FDA acknowledges that there are no documented incidents of illness 
associated with carrot juice sold commercially. This lack of reported 
incidences may be due to lower exposure because of the total amount of 
carrot juice consumed. \5\
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    \5\ Alternatively, it is possible that this lower rate of 
reported incidences is related to some inherent characteristics of 
this product. The agency is aware that research shows that carrot 
juice contains a broad spectrum of antimicrobial activity due to the 
presence of phytoallexins. This activity may be useful as a barrier 
to kill or prevent the growth of Listeria monocytogenes in 
particular, and may possibly also function to keep in check other 
foodborne pathogens and spoilage microorganisms. Nonetheless, the 
conditions under which the antimicrobial effects of carrot juice are 
manifested have not been fully defined. Accordingly, at this time, 
such research does not establish a basis to exclude carrot juice 
from the warning statement requirement.
---------------------------------------------------------------------------

     FDA believes that this absence of documented instances of illness 
does not justify exempting carrot juice from this final rule. According 
to information available to FDA, carrot juice is one of the top three 
fresh juices sold, following orange and apple juice. Because it is 
derived from a root vegetable, carrot juice has the potential to be 
directly contaminated with soilborne pathogens. In addition, carrot 
juice has a higher pH (i.e., it is less acidic) than juices such as 
apple juice or orange juice, and thus, will better support the growth 
of microorganisms, including pathogens, which a juice with a more acid 
pH is more likely to inhibit. In addition, carrot juice itself is a 
rich source of nutrients that will support microbial growth. Therefore, 
the agency concludes that there is no basis to exclude carrot juice 
from Sec. 101.17.
    30. Several comments requested clarification on which products are 
covered by the proposed rule. Comments asked whether a final product 
that contained a diluted pasteurized juice needed to be labeled if the 
final product itself is not pasteurized. Other comments inquired about 
citrus oils, juice concentrates not packaged directly for consumer 
sale, and lemon and lime juice concentrates that are not sold as 
beverages. A few comments asked whether certain juices were subject to 
the warning statement requirement because such juices are sold for use 
as ingredients in other beverages, such as wine or hard cider.
    In considering these comments, FDA identified three questions that 
bear on whether a particular juice product is subject to the warning 
statement requirement. First, does the product meet the definition of 
``juice'' in Sec. 101.17(g)(1)? With respect to the specific products 
described in the comments, FDA advises that juice concentrates not 
packaged for retail sale to consumers meet the definition of ``juice'' 
in Sec. 101.17(g)(1). Likewise, lemon and lime concentrates, which 
often are sold for use as ingredients in beverages such as a blend or 
``punch,'' also meet the definition of ``juice'' under 
Sec. 101.17(g)(1). Finally, juices sold for use as an ingredient in 
either wine or hard cider, which are beverages, are ``juice'' within 
the meaning of Sec. 101.17(g)(1). In contrast, citrus oils are not 
``juices'' under Sec. 101.17(g)(1) because they are not aqueous 
liquids.
    The second question that bears on whether a particular juice 
product is subject to the warning statement requirement is whether a 
product that is ``juice'' within the meaning of Sec. 101.17(g)(1) has 
been processed in a manner that satisfies the pathogen reduction 
performance standard in Sec. 101.17(g)(7); if so, such ``juice'' is 
exempt from the warning statement requirement. Thus, neither a 
pasteurized juice concentrate nor a beverage containing such a 
concentrate would be subject to the warning statement requirement, as 
proposed, because a pasteurized ``juice'' satisfies the pathogen 
reduction performance standard.
    The third question that bears on whether a particular juice product 
is subject to the warning statement requirement is whether the product 
is intended for retail sale to consumers or is being sold for use as an 
ingredient in the manufacture of another beverage. FDA acknowledges 
that, under proposed Sec. 101.17(g)(1), the requirement for a warning 
statement applied to any juice sold as such or used as an ingredient in 
another beverage. FDA's proposal to require the warning statement on 
juice sold for use as an ingredient in another beverage was intended to 
ensure that manufacturers of beverages had access to information about 
whether a juice ingredient that they include in their product had been 
processed in a manner to satisfy the pathogen reduction performance 
standard. Such information is necessary to allow manufacturers of 
beverages to comply with the warning statement requirement. However, 
after consideration of the comments that questioned whether juice sold 
for use as an ingredient is subject to the warning statement 
requirement, FDA has reconsidered its proposal.
    The warning statement is intended to inform consumers of the 
hazards presented by untreated juices so that they may make informed 
choices. Although the use of this warning statement on the label or in 
labeling of a juice product that is being shipped for use solely in the 
manufacture of other foods or that is to be processed, labeled, or 
repacked at a site other than originally processed could serve to 
inform manufacturers who receive the ingredient that the juice is 
untreated, the same goal of providing information to manufacturers 
could be accomplished by customary trade practices. For example, a 
statement that describes whether the juice has, or has not, been 
processed in a manner to meet FDA's pathogen reduction performance 
standard could be included on an invoice or product specification 
sheet.
    Accordingly, in this final rule FDA is adding new Sec. 101.17(g)(3) 
to clarify that juice that is not for distribution to retail consumers 
in the form shipped and that is for use solely in the manufacture of 
other foods or that is to be processed, labeled, or repacked at a site 
other than originally processed, is exempt from the warning statement 
requirement, provided that for juice that has not been processed in the 
manner described in Sec. 101.17(g)(7), the lack of such processing is 
disclosed in documents accompanying the juice, in accordance with the 
practice of the trade.

C. The Proposed Pathogen Reduction Performance Standard

    As discussed in section I of this document, proposed 
Sec. 101.17(g)(6) of the juice labeling proposal is directly linked to 
the pathogen reduction performance standard that is part of the 
agency's HACCP proposal (proposed Sec. 120.24). As discussed in both 
the juice labeling proposal and the HACCP proposal, these two proposed 
regulations would function together as a comprehensive program to 
address the incidence of foodborne illness related to consumption of 
fresh juices and to ultimately address the safety of all juice 
products.
    31. Several comments opposed the pathogen reduction performance 
standard that FDA included in both the juice labeling proposal and the 
HACCP proposal. Under proposed Sec. 101.17(g)(6), the requirement for a 
warning statement would not apply to juice processed in a manner that

[[Page 37040]]

satisfies the pathogen reduction performance standard--i.e., juice 
processed such that there is, at a minimum, a 5-log (i.e., 100,000-
fold) reduction in the pertinent microorganism for a period at least as 
long as the shelf life of the product when stored under normal and 
moderate abuse conditions. (The proposals defined the ``pertinent 
microorganism'' as the most resistant microorganism of public health 
significance that is likely to occur in the juice.) Some comments 
asserted that the 5-log performance standard is unnecessary and 
unreasonable and questioned the scientific basis of the NACMCF 
recommendation of that standard.
    Based on information the agency has received in response to the 
juice labeling proposal, FDA has concluded that the pathogen reduction 
performance standard in proposed Sec. 101.17(g)(6) is the most 
appropriate standard to ensure that juice is safe. The agency advises 
that no food processing method can be shown scientifically to achieve a 
``zero'' probability that a pathogenic microorganism will be present in 
the processed food. However, food processing methods can be shown 
scientifically to reduce, by mathematical increments (i.e., by 
``logs''), the level of pathogens that may be present in food and as a 
result to reduce any potential risk of illness from the food. As 
explained in the HACCP proposal (63 FR 20450 at 20477), the 5-log 
reduction is a performance standard intended to provide assurance that 
juice produced consistent with this standard does not pose more than a 
tolerable level of risk of illness. FDA notes that the 5-log value was 
arrived at by consensus of the Fresh Produce Working Group of the 
NACMCF, and subsequently adopted by the NACMCF, as a target that would 
provide adequate public health assurances while minimizing the impact 
of treatments on the sensory attributes of the juices (Ref. 10).
    With respect to the comment that questioned the basis for the 
NACMCF's recommendation, FDA advises that the agency relied on the 
collective judgment of this group of experts. The comment did not 
present specific challenges to the scientific basis underlying NACMCF's 
recommendation, nor did it provide a basis, data, or other information 
to support any other performance standard.
    For these reasons, these comments have not persuaded FDA to make 
any changes to the pathogen reduction performance standard in proposed 
Sec. 101.17(g)(6).
    32. One comment suggested that a zero tolerance for E. coli O157:H7 
would be more appropriate than the adoption of a performance standard. 
Another comment requested that a ``safe harbor'' bacterial load level 
be added to or used in lieu of the 5-log reduction criteria.
    FDA disagrees with these comments. In general, FDA would consider a 
food product that contains pathogenic microorganisms to be adulterated 
under section 402(a)(1) of the act because it would contain a poisonous 
or deleterious substance that may render the food injurious to health. 
In contrast, FDA considers a total bacterial plate count as an 
indication that the food may have been prepared, packed or held under 
insanitary conditions. FDA would generally conduct an inspection of the 
processing facility to determine whether insanitary conditions exist in 
the facility. If insanitary conditions are found in the facility, any 
food produced under such conditions would be adulterated under section 
402(a)(4) of the act.
    The agency advises that while it could conceivably issue a 
tolerance for E. coli O157:H7, FDA has authority under section 
402(a)(1) of the act to take regulatory action against any juice that 
contains a pathogenic microorganism that may render the juice injurious 
to health. Further, it would be impractical for juice processors to 
establish procedures to ensure actual compliance with such a tolerance 
because it would be necessary to channel a significant portion of the 
end product into testing to provide a statistically valid indication of 
compliance. Finally, a zero tolerance means the pathogens are 
undetectable in the food. For microbiological methods this is about one 
pathogen per 100 grams. For E. coli O157:H7, this is not a safe level. 
In contrast, the performance standard is a way to ensure that the 
presence of E. coli O157:H7 is much lower than that. In addition, the 
performance standard required in proposed Sec. 101.17(g)(6) is a tool 
that can be applied in a practical manner to processing to ensure that 
all the juice has been processed to control pathogens.
    Regarding the use of a ``safe harbor'' bacterial load level, FDA 
considers a ``safe harbor'' bacterial load level to mean a maximum 
total bacterial count. As discussed, under section 402(a)(4) of the 
act, very high aerobic plate counts may indicate that the food has been 
prepared, packed, or held under insanitary conditions, which may 
contribute to increased risk of pathogen occurrence and outgrowth. FDA 
has established regulations in part 110 concerning CGMP in 
manufacturing, packing, or holding human food that already apply to 
juice. Because these regulations directly address appropriate 
conditions for preparing, packing, and holding food, a ``safe harbor'' 
bacterial load level would not directly address such conditions, FDA 
concludes, based on comments received in response to the juice labeling 
proposal, that establishing a ``safe harbor'' bacterial load level is 
not necessary.
    33. One comment stated that the proposed pathogen reduction 
performance standard is premature given that the source of E. coli 
0157:H7 contamination in apples is not known. Additional comments 
questioned whether E. coli 0157:H7 could be found anywhere other than 
in bovine manure.
    The agency disagrees that the proposed pathogen reduction 
performance standard is premature because the source of E. coli O157:H7 
is unknown. First, although E. coli will likely be the ``pertinent'' 
microorganism of public health concern for apple juice, it may not be 
the ``pertinent'' microorganism for other juices. Second, in some 
outbreaks, a likely source has been determined (Ref. 11). Although E. 
coli O157:H7 may be found in bovine manure, there are other possible 
sources for this pathogen, such as deer manure (Ref. 12). Third, 
regardless of its source, E. coli O157:H7 is a pathogen that has been 
found to be present in fresh juice, including apple juice (Ref. 12). In 
fact, the agency's proposed pathogen reduction performance standard is 
a logical response to the comment's assertion that the source of E. 
coli O157:H7 in products such as apple juice is unknown. The knowledge 
that E. coli and other pathogens have been found in juice and have 
caused illness indicates that a processor must take steps (i.e., 
pathogen reduction steps to achieve the performance standard) to ensure 
that juice is safe. These steps must include prevention of 
contamination, destruction of any pathogens of concern that may be 
present, or both. If future research determines new sources of E. coli 
O157:H7 or other pathogens in juice products, processors could then 
develop appropriate measures to prevent contamination from these 
sources and apply measures that are determined to be effective toward 
the pathogen reduction performance standard.
    34. Several comments requested clarification on which aspects of a 
process could be included for the purpose of meeting the proposed 
pathogen reduction performance standard. Respondents asked about the 
appropriate place in the production operation to start measuring 
pathogen reduction and whether specific farming,

[[Page 37041]]

harvesting, and processing practices may be counted toward meeting the 
proposed pathogen reduction performance standard.
    The pathogen reduction process control can begin at the point at 
which the processor has control over the preparation of the product. 
The 5-log reduction may be accomplished cumulatively (e.g., through a 
combination of special culling, use of appropriate sanitizers, and 
specific extraction methods) or by a one-step process (e.g., 
pasteurization). The 5-log reduction standard is designed to achieve 
appropriate microbial risk reduction under all conditions that may be 
encountered in the manufacture of juice, including the conditions in 
which the fruit is grown and harvested. Therefore, farming, harvesting, 
and processing practices may be considered in achieving the 5-log 
reduction, so long as the processor has control over these activities 
and the control measures are effective.
    35. FDA received a number of comments regarding achievement of the 
proposed pathogen reduction performance standard. Some comments 
expressed the opinion that the rule would in essence require 
pasteurization. Other comments asked about options for achieving the 5-
log reduction, such as ultraviolet (UV) radiation, pulsed light, or 
sodium benzoate. Additionally, several comments indicated that 
instituting a ``no dropped fruit'' policy, using potable water, and 
following CGMP's would provide an adequate measure of safety for juice 
products.
    FDA disagrees that the proposal would require pasteurization of 
juice products. While pasteurization currently may be the most 
practical process to achieve the proposed pathogen reduction 
performance standard, it is not the only alternative. A manufacturer 
who demonstrates that the measures discussed in the comments (i.e., use 
of UV radiation, pulsed light, and sodium benzoate) are effective in 
controlling pathogenic microorganisms may apply such measures in 
achieving the pathogen reduction performance standard.
    FDA agrees that the various steps proposed in the comments (e.g., 
``no dropped fruit'') have the potential to contribute to the reduction 
of microbial contamination. Animal manure, whether applied as 
fertilizer or from animals (e.g., cows, deer) present in orchards, can 
be a source of E. coli O157:H7. Not using produce that has come into 
contact with the ground reduces the risk of this contamination. 
However, there are other possible sources of contamination that may not 
be avoided as easily. For example, dust, insects, and birds may be 
vectors of contamination. Likewise, a water supply that does not meet 
the requirements of Sec. 110.37(a) (21 CFR 110.37(a)) that any water 
that contacts food or food-contact surfaces be safe and of adequate 
sanitary quality may also be a source of contamination.
    FDA believes that these comments require no changes to its proposed 
regulations.
    36. Other comments asserted that adherence to State-enforced GMP's, 
quality assurance programs (QAP's), or HACCP programs, or any validated 
HACCP program should be as acceptable as a means of satisfying FDA's 
proposed pathogen reduction performance standard as would be adherence 
to the proposed Federal (i.e., FDA) HACCP program.
     FDA recognizes that State GMP's, QAP's, and HACCP programs can 
serve as a useful foundation to assist processors in achieving public 
health goals and may in fact allow a manufacturer to attain the 
performance standard required by proposed Sec. 101.17(g)(6). 
Nonetheless, these programs vary from State to State and may not exist 
in some States. Therefore, juice that is in interstate commerce may be 
subject to one or more State requirements or to no State requirements. 
Accordingly, FDA continues to see a need for a comprehensive Federal 
regulatory approach for all juice products.
    The agency encourages processors to develop and use an appropriate 
HACCP program in the processing of juice. However, FDA emphasizes that 
it had tentatively concluded in the HACCP proposal that an appropriate 
HACCP program must include control measures that will produce, at a 
minimum, a 5-log reduction in a pertinent microorganism. As noted, the 
warning statement will not be required on products produced under a 
HACCP program validated to achieve the pathogen reduction performance 
standard described in proposed Sec. 101.17(g)(6).
    37. Several comments questioned why, as part of its HACCP program, 
the agency is proposing a pathogen reduction performance standard 
rather than requiring pasteurization. A few comments contended that to 
ensure the safety of juices, the agency should require that all juices 
be pasteurized. Other comments suggested that not all 5-log reduction 
methods are equally effective and that some could be less effective 
than pasteurization.
    The agency does not believe that mandating pasteurization is 
necessary. Pasteurization is one method of achieving the pathogen 
reduction performance standard proposed in the HACCP rule and 
established in this rule as the basis for exemption from the warning 
statement requirement. FDA believes that establishing a performance 
standard rather than mandating the use of a particular process (such as 
pasteurization) provides flexibility in how the pathogen reduction can 
occur and will permit the development of new technology. Importantly, 
however, a performance standard will not preclude the use of 
pasteurization to achieve the standard. The agency recognizes that some 
methods may achieve a 5-log reduction in a more direct manner than 
other methods (i.e., in one step versus in several steps). 
Nevertheless, by its very definition, a 5-log reduction in the 
pertinent microorganism is the same reduction--i.e., a reduction by a 
factor of 100,000--regardless of the method used.
     For these reasons, in this final rule, FDA is maintaining its 
performance standard approach rather than mandating pasteurization.
    38. A few comments stated that pasteurization would not solve all 
the problems with juice and could provide a false sense of security to 
consumers.
    The agency agrees with these comments. Pasteurization does not 
address all problems that may occur during the manufacture of juice and 
that have an adverse effect on public health. Recognition of the 
multiplicity of hazards that are reasonably likely to occur and of the 
need for their control is the basis for the agency's HACCP proposal.
    39. One comment stated that the juice labeling rule was not 
necessary because the pH in cider is too low for pathogens to grow in 
it.
    The agency agrees that acidic pH is generally considered to be an 
unfavorable environment for the survival of pathogens. However, as 
discussed in detail in both the labeling and HACCP proposals, there are 
documented cases of outbreaks of disease caused by E. coli 0157:H7 or 
other pathogens in apple juice and apple cider. Indeed, these outbreaks 
are of particular concern because apple cider typically has an acidic 
pH (i.e., a pH of approximately 3.5 to 4.0), due to the presence of 
malic and lactic acids in apples. Contrary to longstanding beliefs 
regarding microbial tolerance of acidic environments, the available 
evidence shows that E. coli 0157:H7 strains are tolerant of acid pH, 
particularly when held under refrigerated conditions consistent with 
juice manufacturing (Ref. 13). Therefore, the agency believes

[[Page 37042]]

that while acidity may be lethal or inhibitory to some pathogens, it 
cannot be relied upon as a control measure to reduce the risk of 
foodborne illness.
    40. A few comments asked that FDA provide a grace period on 
labeling compliance for processors using a validated HACCP program 
without the pathogen reduction performance standard until the proposed 
HACCP rule for juices becomes final.
    As discussed in the HACCP proposal, the agency has tentatively 
concluded that an adequate HACCP program for juice must include the 
pathogen reduction performance standard in proposed Sec. 120.24. 
Accordingly, the agency incorporated this standard into the juice 
labeling proposal in proposed Sec. 101.17(g)(6). As discussed above, 
there are no data or other information in the comments to the juice 
labeling proposal that demonstrate that the proposed pathogen reduction 
performance standard is not the appropriate standard.
    FDA acknowledges that comments that are submitted to the HACCP 
proposal may persuade the agency to implement an alternative to the 
pathogen reduction performance standard set out in the HACCP proposal. 
However, in the interim between the issuance of this final rule and any 
final rule based on the HACCP proposal, it is the agency's best 
judgment, based on the information in the administrative record of this 
proceeding, that any HACCP program that does not satisfy the proposed 
pathogen reduction standard--i.e., a 5-log reduction in the pertinent 
microorganism--cannot be considered adequate for safe juice production, 
and thus, cannot provide the basis for exempting a product from the 
warning statement requirement. Accordingly, in this final rule, FDA is 
retaining (as Sec. 101.17(g)(7)(i)(A)) the provision of proposed 
Sec. 101.17(g)(6) that the requirement for a warning statement not 
apply to juice processed in a manner that will produce, at a minimum, a 
5-log (i.e., 100,000 fold) reduction in the pertinent microorganism for 
a period at least as long as the shelf life of the product when stored 
under normal and moderate abuse conditions.
    However, in recognition of the fact that the agency has not 
completed its rulemaking on the HACCP proposal, in this final rule FDA 
is broadening the exemption from the warning statement requirement in 
proposed Sec. 101.17(g)(6) to include (as Sec. 101.17(g)(7)(i)(B)) 
juice processed in a manner that will achieve or exceed any pathogen 
reduction performance standard ultimately established in any final 
regulation requiring the application of HACCP principles to the 
processing of juice. In the event that the agency's judgment when it 
completes the HACCP rulemaking is that the interim pathogen reduction 
performance standard is more strict than necessary, this amendment will 
automatically ensure that manufacturers would be able to use the final 
HACCP pathogen reduction performance standard in determining whether 
their juice products require the warning statement. In the event that 
the agency's judgment when it completes the HACCP rulemaking is that 
the interim pathogen reduction performance standard should be altered, 
FDA will take the appropriate steps to amend this rule.
    41. A few comments stated that a HACCP program (without a 
performance standard) is adequate because there is no evidence of 
foodborne illness in fresh apple juice or cider from processors using 
HACCP programs with GMP's, sanitation standard operating procedures 
(SSOP's), and raw material standard operating procedures (SOP's).
    The issues raised in these comments are beyond the scope of this 
labeling document. The agency notes that it has tentatively concluded 
in the HACCP proposal that an appropriate HACCP program must include 
control measures that will produce, at a minimum a 5-log reduction in a 
pertinent microorganism. The basis for the proposed requirement was 
discussed in that proposal (63 FR 20450 at 20477). FDA will respond to 
these comments fully in the HACCP final rule.
    42. Several comments requested guidance on how to determine if 
their process meets the 5-log reduction.
    There are essentially two ways for processors to determine if their 
process accomplishes a 5-log reduction in a pertinent microorganism. 
Processors or other entities (such as researchers or a State) may test 
a particular process with a known level of the target pathogen or an 
appropriate surrogate microorganism that possesses similar properties 
to the target pathogen and determine whether the process is reducing 
the microorganism to the appropriate level. Alternatively, 
manufacturers of processing equipment or sanitizers may test the 
process that they are recommending for juice processing and supply the 
applicable information on their product to the juice processor. 
Consistent with customary scientific practices, the method that 
produces the 5-log reduction should be validated.
    As discussed in the HACCP proposal (63 FR 20450 at 20478), the 
agency noted that it may be feasible for a processor to achieve a 5-log 
reduction in a target pathogen in citrus juice using a combination of 
CGMP's, sanitation SOP's, and the following three measures: (1) Culling 
and grading, (2) washing, brushing, and sanitizing, and (3) appropriate 
methods of extraction. If this procedure is validated, it is unlikely 
that processors of fresh orange juice, and perhaps other fresh citrus 
fruit juices, will have to implement pasteurization in order to achieve 
a 5-log reduction in pathogenic bacteria.
    In fact, the agency believes that citrus processors should be able 
to achieve and validate a 5-log reduction without pasteurization. To 
provide more detail, a system that could achieve a 5-log reduction 
without pasteurization would likely include, at a minimum: Strict 
control of incoming material to ensure fruit are intact and clean 
(including not using dropped fruit); effective employee hygiene and 
facility sanitation; appropriate chemical sanitizers; juice extraction 
equipment that minimizes contact of juice with peel; refrigeration 
immediately after juicing; and bottling in a closed system to minimize 
environmental contamination. FDA would be willing to meet with 
manufacturers or groups of manufacturers to discuss and evaluate their 
proposed processes.
    In addition, the agency will make available, in accordance with 
part 20 of the agency's regulations (21 CFR part 20), information on 
various processes that it learns have been validated to achieve a 5-log 
reduction in order to help processors meet the performance standard.
    43. One comment requested a definition of ``moderate abuse 
conditions.''
    Moderate abuse conditions, as described in the HACCP proposal (63 
FR 20450 at 20478), occur when unusual circumstances arise during 
regular handling of the product. Unloading a truck on a hot day where 
the product may sit on a loading dock for a short period of time is one 
example of moderate abuse. Another example of moderate abuse is 
illustrated by a consumer who purchases a product on a warm day, places 
it in a car, and then runs errands before refrigerating the product. In 
FDA's view, moderate abuse does not include exposure to high 
temperatures for extended periods of time.

IV. The Warning Statement

A. General Comments

    In the juice labeling proposal, FDA tentatively concluded that 
certain informational elements were essential to the warning statement, 
i.e., the statement of the hazard, a description of

[[Page 37043]]

why the product may have the hazard, and an identification of the 
consumers at greatest risk. Consequently, FDA proposed to require the 
following warning statement on covered products:
    WARNING: This product has not been pasteurized and, therefore, 
may contain harmful bacteria which can cause serious illness in 
children, the elderly, and persons with weakened immune systems.
    In this final rule, FDA is replacing the phrase ``which can cause 
serious illness * * *'' with the phrase ``that can cause serious 
illness * * *''. This change provides clarity and is not a substantive 
change.
    44. Some comments generally opposed the language in the warning 
statement on the grounds that it is frightening, confusing or 
misleading. Some of these comments contended that consumers associate 
warning statements with products such as pesticides, poisons, or 
carcinogens.
    The agency's intent in requiring a warning statement on untreated 
juices is to inform consumers that such juices may contain harmful 
bacteria that can cause serious illness in children, the elderly, and 
persons with weakened immune systems. This statement will ensure that 
consumers have the information that they need to make informed choices. 
To achieve this goal, the statement needs to present information about 
the hazard. By its very nature, any statement that informs consumers 
about a hazard, particularly a hazard that consumers do not expect, 
would be, to some extent, ``frightening.''
    FDA conducted consumer focus group research to anticipate the 
likely impact of these statements on the public. This research tested 
variations in wording to evaluate whether different statements and 
specific words would produce exaggerated or inappropriate consumer 
understanding.
    Some participants initially considered the warning statement to be 
alarming because it appeared to contradict their assumption, based on a 
lifetime of experience consuming these products, that all juices are 
safe and healthful foods. However, most of the focus group participants 
who were alarmed by the statements mistakenly assumed that juice 
products that they routinely consumed were not processed to control 
pathogenic microorganisms. After receiving information that untreated 
juice comprises less than 5 percent of all juice consumed, and that 
most juice products in supermarkets are processed to control pathogenic 
microorganisms, focus group participants were much less alarmed by the 
warning statements. Importantly, after receiving this information, many 
focus group participants appreciated the warning statement because they 
recognized that it would help them distinguish juice products that were 
more safe from those that are less safe because the latter products may 
contain pathogenic microorganisms. Even consumers of untreated juice 
products such as unpasteurized apple cider were reassured to know that 
the warning statement would be applied to a narrow and distinctive 
segment of juice products that had characteristics that specifically 
warranted the statement because such products had not been processed to 
control pathogenic microorganisms.
    Based on this focus group research, FDA concludes that giving 
consumers accurate information on untreated juices to better inform 
their choices is likely to have the desired effect.
    45. One comment suggested that the warning statement be changed to 
reflect that contamination of unpasteurized cider is the cause of a 
potential hazard. The comment contended that FDA's proposed statement 
seems to suggest that the presence of harmful bacteria is a matter of a 
statistical chance and is inherent in the cider, rather than a 
consequence of contamination of the cider.
    FDA disagrees with this comment. While FDA has determined that the 
fact that bacteria may be present in juice is a material fact within 
the meaning of section 201(n) of the act, the agency is not persuaded 
that the process by which the bacteria came to be present is also 
material information. The comment did not provide a rationale for why 
the information on what causes bacteria to be present in juice is 
material with respect to the health hazard. Therefore, the agency is 
not making this suggested change.

B. Comments on the Term ``Warning''

    46. Some comments that supported the use of the word ``WARNING'' in 
the warning statement asserted that this very explicit term is 
necessary so that consumers notice and give appropriate attention to 
the hazard message. Other comments recommended specific alternatives to 
the term ``WARNING,'' such as ``NOTICE,'' ``CONSUMER ADVISORY,'' 
``CONSUMER ALERT,'' ``HAZARD NOTICE,'' ``HAZARD ADVISORY,'' or ``HAZARD 
ALERT.'' Some of these comments suggested that the term ``WARNING'' be 
used only for apple juice and that an alternative term, such as 
``NOTICE,'' ``ATTENTION,'' or ``CONSUMER ADVISORY'' be used for juice 
products that pose a lower risk than that posed by apple juice. One 
comment noted that for oysters a consumer advisory rather than a 
warning statement is used to inform consumers of the hazard associated 
with Vibrio vulnificus which has a 50 percent mortality rate associated 
with illness. Comments acknowledged that the use of the same term for 
all juice products, even those perceived to be of lower risk, may 
nonetheless be necessary in the interest of uniformity.
    FDA disagrees with those comments that suggested that another term 
be substituted for ``warning'' because the results of the focus group 
research support the use of the term ``warning.'' Focus group 
participants examined warning statements that used four signal words, 
i.e., ``WARNING,'' ``NOTICE,'' ``CAUTION,'' AND ``ATTENTION.'' 
Participants preferred ``WARNING'' and ``CAUTION'' over ``NOTICE'' and 
``ATTENTION'' because these terms were perceived to be stronger and 
more likely to cause consumers to read the message; participants 
believed that the word ``WARNING'' was the strongest term. In addition, 
in identifying their preferred warning statement, most participants 
preferred the message preceded by the signal word ``WARNING.'' Other 
terms recommended in the comments, such as ``CONSUMER ADVISORY,'' were 
not tested in the agency's consumer research. Terms such as ``CONSUMER 
ADVISORY'' or ``CONSUMER ALERT'' are moderate signal terms, falling 
between the stronger signal terms tested (``WARNING'' and ``CAUTION'') 
and the weaker signal terms tested (``NOTICE'' and ``ATTENTION''). 
Consumers in the focus groups clearly preferred a strong signal to 
alert them to the warning statement. The term ``WARNING'' was viewed as 
a simple and unambiguous signal because it is a familiar word that most 
people readily understand. The comments that suggested alternative 
terms to ``WARNING'' did not provide consumer data or a compelling 
rationale to support their recommendations. FDA has conducted several 
studies of warning messages (in addition to juice) and has concluded 
that consumer testing of proposed language enhances the likelihood that 
warning messages will correctly communicate critical information (Ref. 
5). Accordingly, because the relevant comments provided no consumer 
data or compelling rationale to support the use of alternative signal 
words, FDA has concluded that the warning statement for juice products 
should utilize the signal word ``warning,'' a signal that is supported 
by consumer research data. Furthermore, the agency believes that

[[Page 37044]]

warning is the more suitable term because it is consistent with past 
agency regulations (e.g., Sec. 101.17(a), (b), (d)(1), and (e)) that 
use a term stronger than ``notice.''
    The purpose of the warning statement is to inform consumers of the 
risks presented by certain juice products, thereby allowing them to 
make better decisions about the purchase and consumption of such 
products. This goal can only be achieved to the extent that consumers 
read and process the warning statement. Accordingly, FDA believes that 
it is appropriate to require the signal term that consumers say would 
be most likely to cause them to read the statement. Therefore, FDA is 
retaining ``warning'' as the signal word for the statement required by 
this rulemaking.

C. Comments on the Phrase ``Has Not Been Pasteurized''

    47. Some comments stated that the phrase ``has not been 
pasteurized'' is inappropriate in the context of the warning statement 
because it is misleading. A few of these comments asserted that 
pasteurization provides a safer product than other processes that would 
satisfy FDA's proposed pathogen reduction performance standard. These 
respondents contended that the use of ``has not been pasteurized'' is 
potentially harmful because consumers might believe that all products 
that did not bear such a warning statement had been pasteurized and 
were equally safe.
    The agency disagrees with these comments. FDA maintains that 
products processed in a manner to achieve the pathogen reduction 
performance standard would achieve an appropriate level of safety, 
whether they had been processed by pasteurization or by some other 
means. Products that have not been processed to achieve the pathogen 
reduction performance standard would require the warning statement. 
Therefore, the agency concludes that the message that the consumers 
would take from the warning statement is that products bearing the 
warning may have potential hazards, whereas those not bearing the 
statement are processed to ensure safe products.
    48. Some comments contended that the term ``has not been 
pasteurized'' is too narrow a term for the warning statement. While the 
comments did not oppose the term ``pasteurized,'' the comments asserted 
that consumers should be made aware that pasteurization is not the only 
means by which juice products can be processed safely. The comments 
argued that technology can move quickly, and that use of the term 
``pasteurized'' would limit the development of new technology for 
processing juice to destroy pathogenic microorganisms. Therefore, two 
of the comments suggested the following language: ``this product has 
not been pasteurized or otherwise treated * * *.''
    FDA acknowledges that the term ``has not been pasteurized'' is not 
technically precise in the context of the warning statement, because 
products that have not been pasteurized, but have been otherwise 
processed to meet the pathogen reduction performance standard, do not 
need to bear the warning statement. In other words, the warning 
statement will not be required on all juice products that have not been 
pasteurized because those products subject to a process that achieves 
the 5-log reduction standard, other than pasteurization, do not need to 
bear the warning statement. However, as discussed in the juice labeling 
proposal, FDA proposed the phrase because consumer focus group 
participants understood the term ``has not been pasteurized'' better 
than the term ``has not been specifically processed.'' Moreover, as 
discussed in the juice labeling proposal, the agency believes that the 
more important message, i.e., that juice products not treated to remove 
pathogens present some risk, particularly for certain population 
groups, will be clearly understood by consumers. The comments did not 
provide information to show that consumers would be confused by the 
warning statement. Therefore, the agency is not adopting this suggested 
modification to the warning statement.

D. Comments on the At-Risk Groups

    Most comments supporting the proposed labeling requirements 
generally supported the proposed description of the consumers at risk, 
although some comments suggested that these groups should be better 
defined.
    49. One comment maintained that the warning statement should be 
modified unless specific data can be presented on the risks and those 
at risk. Another comment questioned whether ``children'' meant persons 
under 18. Another comment suggested that the term ``children'' be 
replaced with the term ``infants.'' This comment noted that when 
botulism was a concern in honey, only parents of children under 1 year 
old had to be concerned. Other comments stated that the term 
``children'' was appropriate because there is no scientific basis for 
excluding older children and because parents will recognize that 
infants and young children are included in the broad category of 
``children.''
    Some comments questioned what is meant by the term, ``elderly.'' 
One comment suggested that the term ``elderly'' be replaced with the 
term ``senior (50 years or older),'' whereas another comment 
recommended that ``elderly'' be replaced with ``senior (55 years or 
older).''
    FDA disagrees that the word ``infants,'' which ordinarily refers to 
children less than 1 year old, should replace ``children'' in the 
warning statement because some of the foodborne illnesses associated 
with consumption of juice occurred in children older than 1 year. 
Therefore, FDA concludes that use of the word ``infants'' in lieu of 
``children'' would be misleading.
    In the juice labeling proposal, FDA relied on a task force report, 
from the Council for Agricultural Science and Technology (CAST), that 
concluded that certain groups (i.e., young children, the elderly, and 
persons who are immunocompromised) are at greatest risk of serious 
illness from exposure to foodborne pathogens (63 FR 20486 at 20489). 
The report did not define a precise age range for either ``children'' 
or ``the elderly.'' The comment that questioned whether specific data 
was available to support FDA's description of the at-risk groups did 
not provide any data on which to refine the descriptive terms used in 
the report.
    FDA recognizes that the terms ``children'' and ``elderly'' are not 
precise. They are terms chosen by the Council for Agricultural Science 
and Technology to reflect groups that, in general, have an immune 
system that is either incompletely developed or beginning to decline. 
Although the exact age at which a child's immune system is fully 
developed is not precisely defined and will depend on the individual 
development of the child, the task force report indicated that the 
incompletely developed immune system of infants and children younger 
than 5 makes this age group especially susceptible to foodborne 
illness. In addition, the report noted that the infective dose may be 
related to body weight, which would be less for younger children. 
Nonetheless, the median age of persons who experienced illness in a 
recent outbreak of E. Coli O157:H7 infections associated with juice 
products was five (Ref. 14); thus, as many individuals older than 5 
years experienced illness as did those under 5 years. Therefore, the 
agency believes that the descriptive term for ``children'' in the 
warning statement should not be limited, e.g., to ``young children'' or 
to children 5 years and under.

[[Page 37045]]

    Likewise, the task force report stated that elderly individuals 
undergo a decrease in immune function that makes them more susceptible 
to foodborne illness than the general population. The report both 
indicated that this decrease in the immune system can occur as early as 
50 to 60 years of age and designated the term ``elderly'' to mean an 
individual over 65. Because the range given by the task force was so 
wide, the agency tentatively concluded that it had no basis for 
identifying a specific age for its category of ``elderly'' in the 
warning statement.
    In the juice labeling proposal, FDA asked for comments on whether 
the age groups for children and the elderly could be better defined. 
Although some of the comments to the proposal suggested that the 
warning statement specify particular ages, the comments did not provide 
a substantive basis for any of these recommended ages. Accordingly, FDA 
is making no changes to the terms ``children'' or ``the elderly'' in 
the warning statement.
    50. One comment stated that either the risk groups should be better 
defined or no risk groups should be mentioned at all.
    FDA disagrees with this comment. Although the at-risk groups are 
not described as precisely as some might wish, as noted, there are few 
available data to identify the ages of children and adults who are at 
high risk. FDA has concluded that it is preferable to identify the at-
risk groups with slightly imprecise terms than not to designate such 
groups at all. Therefore, FDA rejects this comment.
    51. Several comments suggested that pregnant women be included as 
at-risk consumers. Only one comment provided any rationale for this 
addition, stating that pregnant women, who during their pregnancies 
have impaired immune systems, allegedly do not recognize that they are 
at greater risk of infection. Another comment pointed out that pregnant 
women are at risk of having miscarriages if they are infected with 
Listeria.
    FDA disagrees with the suggestions that pregnant women be included 
in the at-risk groups. FDA acknowledges that the CAST report noted that 
the immune system of a pregnant woman is altered to some extent 
compared to that of a non-pregnant woman. In looking at the populations 
at greatest risk from foodborne pathogens, CAST identified pregnant 
women as a group at risk from L. monocytogenes, a widely distributed 
pathogen that has been associated with miscarriages. Nonetheless, there 
is no evidence that pregnant women or their fetuses are at any greater 
risk of serious illness from the foodborne pathogens associated with 
juices than the general population. The agency notes that Listeria has 
not been identified in the documented cases of illnesses associated 
with consumption of untreated juices. Therefore, FDA has no basis for 
determining that risk to a pregnancy from Listeria is any greater from 
the consumption of juices than from the consumption of all other foods.
    52. Several comments stated that the term ``serious illness'' 
should be replaced with ``life threatening illness.'' These comments 
asserted that it is important that high risk consumers are adequately 
informed of the potential risks and therefore, the language should be 
explicit enough so that they will avoid the product. According to one 
comment, the language should be explicit enough so that consumers will 
overcome the presumption that the warning is meant for someone else.
    FDA disagrees with these comments. The term ``serious illness'' is 
an accurate description of the hazard. Moreover, the FDA focus group 
research tested a variety of messages that included the phrases 
``serious illness'' and ``life-threatening illness.'' The participants 
preferred a phrase such as ``serious illness'' because it conveyed a 
significant consequence without being too extreme. In addition, 
participants viewed ``serious illness'' as a strong statement for 
persons with weakened immune systems or immature immune systems such as 
young children. In contrast, participants viewed terms such as ``life-
threatening'' or ``death'' as less credible. Thus, in addition to being 
objectively conceived, FDA focus group research confirmed that the 
phrase ``serious illness'' is subjectively understood. Accordingly, FDA 
is making no changes in response to these comments.

E. Comments on the Entire Warning Statement

    53. In contrast to the comments that suggested alternatives for 
specific words or phrases in the proposed warning statement, a few 
comments suggested alternative wording for the entire warning 
statement. As examples, comments suggested statements such as the 
following:
     This is a natural product that has not been pasteurized or 
otherwise treated. There is a slight risk that it may inadvertently 
contain harmful bacteria that can cause serious illness in children, 
the elderly and persons with weakened immune systems.
     CONSUMER ADVISORY: Unless specifically processed, some juices 
may contain harmful bacteria known to cause serious illness. This 
product has not been processed to destroy these bacteria. The risk 
of life-threatening illness is greatest for children, the elderly, 
and persons with weakened immune systems.
    NOTICE: This product has not been processed to eliminate the 
possibility of harmful bacteria and, therefore, could cause serious 
illness to those with weak immune systems, and young children.
     Attention: This is a fresh juice. It has not been pasteurized. 
There is a small possibility it could be harmful to those with weak 
immune systems.
None of these comments provided a compelling rationale for why the 
suggested statement was more appropriate than FDA's proposed statement.
    FDA's statement was developed and refined based on focus group 
research that tested multiple warning statements. Because the comments 
that suggested alternative wording for the entire statement did not 
provide a sufficient basis to dispute the findings of the focus group 
studies, FDA is not adopting any of these general suggestions.

F. Comments on Prominence and Placement

    54. In the juice labeling proposal, the agency tentatively 
concluded that the warning statement should appear on the food label in 
a manner that makes it readily observable and likely to be read. 
Accordingly, FDA proposed that the statement appear prominently and 
conspicuously on the information panel or on the principal display 
panel (PDP) of the product label. Under Sec. 101.2(c) (21 CFR 
101.2(c)), information required to appear on the PDP and information 
panel must appear prominently and conspicuously in a type size no less 
than one-sixteenth inch. The agency also proposed that the word 
``warning'' immediately precede the statement, appear in capital 
letters and bold type, and that the statement be set off in a box by 
use of hairlines.
    In this final rule, FDA is revising proposed Sec. 101.17(g)(4) (now 
Sec. 101.17(g)(5)) to remove the provision that the term ``WARNING'' 
immediately precede the remainder of the warning statement. FDA is 
making this change, which is not substantive, because it is redundant 
with the requirements of Sec. 101.17(g)(2), which explicitly places the 
term ``WARNING'' in front of the remainder of the statement.
    55. One comment urged FDA to require that the warning statement 
appear on the PDP and not the information panel. The comment neither 
disputed the rationale that FDA presented in the juice labeling 
proposal in support of its proposal to allow the warning statement to 
appear on either the information panel or the PDP nor gave a reason for 
its request. Therefore,

[[Page 37046]]

the agency is making no changes in the location of the warning 
statement in response to this comment.
    56. One comment maintained that the statement should not be set off 
by hairlines and that the agency should follow the same guidelines that 
it used for other informational statements such as those for saccharin 
and phenylalanine.
     The agency disagrees with this comment. The agency's recent 
experience with the Nutrition Facts panel has been that the use of 
hairlines (i.e., enclosing the critical information in a box) greatly 
increases the prominence of the information. Also, focus group research 
has shown that such boxes help consumers distinguish the message from 
other information on the food label. As noted, the warning statement 
will achieve its purpose only if it is seen and read by consumers. 
Therefore, the agency is making no changes in response to this comment.
    57. A few comments that supported the use of warning statements on 
juice products stated that a minimum type size of one-sixteenth inch is 
too small to attract consumer attention. One comment asserted that the 
proposed type size is too small to be read by many of the elderly, who 
are one of the at-risk groups targeted by the warning statement. The 
comment recommended a type size no smaller than 8-point on labels. 
Another comment suggested a minimum type size of three-sixteenth inch.
    The agency does not have data from the comments or elsewhere that 
indicate that consumers are unable to obtain the information from other 
warning statements required in Sec. 101.17 and thus, has no reason to 
believe that consumers would not be able to obtain information from the 
warning statement in this rule. Accordingly, FDA is making no change to 
the minimum type size requirements for warning statements for 
unprocessed juice products.

V. Other Issues

    58. A few comments urged FDA to require pasteurized juices to bear 
a label informing consumers that the product had been pasteurized. 
These comments contended that juices that have been pasteurized, i.e., 
heat treated, have lost some of their ``beneficial'' nutrients, e.g., 
pectin, and certain enzymes and vitamins, and that consumers have a 
right to this information. The comments further stated that requiring 
pasteurized juices to bear a label indicating that the product was 
pasteurized would prohibit manufacturers of pasteurized juice from 
labeling their products as ``fresh.''
    The agency does not object to manufacturers voluntarily labeling 
their product as ``pasteurized,'' when the product has, in fact, been 
heat treated in accordance with the practice of the trade. However, to 
require the term ``pasteurized'' on juice products the agency would 
have to find that such information was material in light of 
representations made about the product, or with respect to consequences 
that may result from use of the product. The comments did not provide 
the agency with any information on which to make either of these 
findings. Therefore, the agency is not requiring that the term 
``pasteurized'' or any similar term, i.e., heat treated, appear on the 
label of juice that has been pasteurized. The agency advises that 
labeling a pasteurized juice product as ``fresh'' is a misbranding 
violation under section 403 of the act. Such products are subject to 
regulatory enforcement action.
     59. Some comments questioned whether the requirement for a warning 
statement would apply to products that were manufactured by producers 
who process their own fruit and sell the resulting fresh juice products 
directly to consumers at their own retail markets, such as a roadside 
stand.
    Whether the warning statement applies to these products depends on 
two factors: The ``retail'' status of the producer and the jurisdiction 
of the FDA.
    The source of FDA's authority here is the act. Under the act, FDA's 
jurisdiction extends to those products, and the manufacturers and 
distributors of regulated products, that satisfy a necessary connection 
with interstate commerce. (See 21 U.S.C. 301 and 304.) Juice that is a 
product of solely intrastate activities (e.g., source of components, 
location of sales, etc.) is not subject to FDA's jurisdiction and thus, 
would not be subject to the warning statement requirement.
    Nonetheless, in such circumstances, FDA customarily works with 
State regulatory agencies such as local health departments, who, like 
FDA, have a mission to protect the public health. Elsewhere in this 
final rule, FDA has addressed several comments submitted to the juice 
labeling proposal that described actions already taken by the States to 
work with producers to ensure the safety of juice products.
    60. Several comments asked whether the responsibility for providing 
a placard or sign, which is an acceptable interim mechanism for 
manufacturers of packaged juices to comply with the juice labeling 
rule, lay with a manufacturer who produces the juice and sells it to a 
wholesaler or retailer or lay with the retailer who actually sells the 
juice to individual customers.
    Under the applicable law, regulations, and agency policy, the firm 
that is identified as the manufacturer or distributor on the product 
label bears the principal responsibility to ensure that the product 
meets all applicable legal requirements, including labeling. However, 
retailers and wholesalers also have legal responsibility to ensure that 
products they sell are properly labeled. The legal basis for this 
shared responsibility is as follows.
    Section 301 of the act (21 U.S.C. 331) prohibits the interstate 
shipment of a misbranded food and also prohibits the misbranding of a 
food after interstate shipment. In the case of the juice labeling rule, 
a juice product that is required to, but does not, bear the warning 
statement is misbranded within the meaning of sections 403(a)(1) and 
201(n) of the act. A manufacturer or distributor who ships a misbranded 
juice product would violate section 301(a) of the act. Likewise, a 
retailer who fails to provide required labeling containing a warning 
statement would violate section 301(k). As is FDA's general practice, 
the agency would evaluate on a case-by-case basis any situation 
involving a possible misbranding of a covered juice product to 
determine whether any regulatory action was warranted.
    61. Some comments asked whether States would be responsible for 
enforcing the warning statement requirement for products in intrastate 
commerce.
    State enforcement activities related to this final rule will depend 
upon the specifics of each State's law (e.g., does that law provide for 
the automatic adoption of Federal regulations or does that law require 
a separate State process to establish a State standard?) and the 
exercise of the State's enforcement discretion.
    As a practical matter, the agency is aware that a number of States 
have already begun to work with producers to improve the safety of 
juice products. One of FDA's goals in establishing a Federal 
requirement is to assist States in their efforts and to provide a model 
to encourage consistency in approach.
    62. One comment strongly urged FDA to exempt all growers who 
process juice and sell directly to consumers at their own retail 
markets regardless of sales volume. The comment based the request on 
the belief that the labeling proposal exempted from the warning 
statement requirement growers who processed their own fruit and sold 
less than 40,000 gallons of the resulting juice products

[[Page 37047]]

directly to consumers and other retailers.
    FDA is clarifying that its proposal to require warning statements 
on untreated juice products did not exempt juices produced by 
processors that sold less than 40,000 gallons. On the contrary, the 
agency proposed in the juice labeling proposal that the warning 
statement appear on the packages of all untreated juice products. 
Growers, in general, who process their own fruits and sell the 
resulting juice products commercially are not exempted by FDA from the 
warning statement requirement based on sales volume. The comment failed 
to provide the agency with a basis on which to exempt small growers 
from the labeling requirement, and therefore, the agency declines to do 
so.
    63. Several comments objected to the abbreviated time for comments 
on the juice labeling proposal. One comment specifically asserted that 
the shortened comment period resulted in a denial of procedural due 
process to the industry and the public.
    The juice labeling proposal provided interested persons with 30 
days to comment on the proposal. In the proposed rule, the agency 
articulated the basis for its decision under Executive Order 12889 and 
FDA's regulations, Sec. 10.40(b), for shortening the comment period to 
30 days. Subsequently, several interested persons requested an 
extension of the time for comments. As discussed above, the agency 
ultimately extended, on June 10, 1998, under the authority of 
Sec. 10.40(b)(3), the period for comments from all interested persons 
to June 22, 1998. The agency believes that this comment period is 
consistent with customary practice and agency regulations. The agency 
believes that the public health urgency that underlies this rulemaking 
is sufficient justification under Executive Order 12889 to shorten the 
comment period from 75 days, a conclusion not challenged in the 
comments. The agency also believes that the comment schedule of this 
rulemaking is in compliance with due process. FDA's process here is 
consistent with the requirements of the Administrative Procedure Act (5 
U.S.C. 553). Such requirements are consistent with due process. (See 
Bell Lines, Inc. v. U.S., 263 F. Supp. 40 (D. W. Va. 1967).)

VI. Effective Date

    In the juice labeling proposal, FDA proposed that any final rule 
based on the proposal become effective 60 days after its date of 
publication in the Federal Register.
    64. The majority of comments that addressed the proposed effective 
date supported a 60-day effective date because of the public health 
concern presented by untreated juices. A few comments asked that the 
agency change the effective date. One comment suggested that the 
effective date be changed from 60 to 120 days to allow small processors 
time to implement HACCP-based programs. Another comment asserted that 
the 60-day effective date was appropriate if FDA wanted to reach the 
1998 apple cider season. That comment suggested, however, that the 
effective date for other juices be extended to 150 days.
    As discussed in the juice labeling proposal, the agency has 
determined that the urgency of the public health concern with untreated 
juices requires the mandating of a warning statement as soon as 
possible, and, in particular, in time for the 1998 ``cider season.'' 
The comments did not provide any information that contradicted FDA's 
tentative conclusion that an effective date of 60 days would be needed 
to coincide with the beginning of the fresh juice season for apple 
juice and apple cider. Accordingly, the agency is retaining the 60-day 
effective date for this final rule. Apple juice and apple cider must 
comply on the effective date of the final rule.
    The overarching public health goal of this rulemaking is to provide 
information about the potential hazards of untreated juice products to 
consumers at the beginning of the next applicable ``juice season.'' 
Apple juice and orange juice are the two most consumed juices in the 
United States, and together account for approximately 80 percent of all 
juice consumed in the United States (63 FR 24254 at 24365). As 
discussed in the PRIA (63 FR 24254 at 24273), information available to 
FDA indicates that the season for apple cider production runs primarily 
from September through December. Other information available to FDA 
indicates that the fresh juice season for citrus fruit generally runs 
from November through June (Ref. 15). Thus, the agency's public health 
goal can be achieved by establishing a compliance date for citrus juice 
products that coincides with the start of the fresh citrus juice 
season. FDA is not aware that the fresh juice season for any juice 
other than apple juice or apple cider begins as early as the apple 
juice and apple cider season. Accordingly, in this final rule, FDA is 
establishing a compliance date for all juices other than apple juice or 
apple cider at 120 days after the date of publication of the final 
rule.
    As discussed above, in this final rule, Sec. 101.17(g)(4) provides 
that the required warning statement may be provided in labeling at the 
point of purchase on a temporary basis until 1 year from the date of 
compliance with the final rule. In essence, this provision provides 
manufacturers the alternative of using labeling (e.g., signs or 
placards) for a single juice season. This flexibility will postpone by 
a juice season a manufacturer's need to revise and reprint labels that 
would be affixed to packaged untreated juice products.

VII. Summary of Provisions

    In this final rule, FDA is revising its food labeling regulations 
by requiring a warning statement on fruit and vegetable juice products 
that have not been processed to prevent, reduce, or eliminate 
pathogenic microorganisms that may be present. FDA is taking this 
action to inform consumers that such juices may contain harmful 
bacteria that can cause serious illness in children, the elderly, and 
persons with weakened immune systems. FDA expects that providing this 
information to consumers will allow them to make informed decisions on 
whether to purchase and consume untreated juice products, thereby 
reducing the incidence of foodborne illnesses and deaths caused by the 
consumption of these products. The requirement that untreated juice 
products bear a warning statement is part of a comprehensive program, 
which may include the establishment of HACCP principles proposed for 
the processing of juice products, to address the incidence of foodborne 
illness related to consumption of fresh juices and to ultimately 
address the safety of all juice products.
    This juice labeling final rule includes the following revisions to 
the juice labeling proposal:
    (1) Section 101.17(g)(1) has been revised to remove the provision 
that any juice sold as such or used as an ingredient in beverages is 
subject to the warning statement requirement. This proposed provision, 
which specified those products that are subject to the warning 
statement requirement, became redundant with the final provisions of 
Sec. 101.17(g)(2) and (g)(3).
    (2) Section 101.17(g)(2) has been revised to reflect that, in 
addition to any juice that has not been processed to satisfy the 
pathogen reduction performance standard in Sec. 101.17(g)(7), the 
warning statement requirement applies to any beverage containing juice 
where neither the juice ingredient nor the beverage has been processed 
to satisfy that standard. This, together with the exemption in 
Sec. 101.17(g)(3), clarifies how FDA intended to cover juice used as an 
ingredient.

[[Page 37048]]

    (3) New Sec. 101.17(g)(3) establishes an exclusion from the warning 
statement requirement for certain juice that is not for distribution to 
retail consumers in the form shipped and that is for use solely in the 
manufacture of other foods or is to be processed, labeled, or repacked 
at a site other than originally processed. A warning statement is not 
required for such juice even if it has not been processed in the manner 
described in Sec. 101.17(g)(7), so long as the lack of such processing 
is disclosed in documents accompanying the juice, in accordance with 
the practice of the trade.
    (4) Under Sec. 101.17(g)(4), the compliance date for the rule 
depends on the nature of the juice. For apple juice and apple cider, 
the compliance date is 60 days after the date of publication in the 
Federal Register; for all juices other than apple juice and apple 
cider, the compliance date is 120 days after the date of publication in 
the Federal Register.
    (5) Under Sec. 101.17(g)(4), manufacturers of packaged juices may 
comply with the rule by means of point-of-sale labeling, e.g., through 
the use of signs or placards, for up to 1 year after the date for 
compliance with the rule. In essence, this provision provides all 
manufacturers, regardless of size, the alternative of using labeling 
for a single juice season.
    (6) The provision in proposed Sec. 101.17(g)(4) (now 
Sec. 101.17(g)(5)) that the term ``WARNING'' immediately precede the 
remainder of the warning statement has been deleted because it is 
redundant with the requirements of Sec. 101.17(g)(2).
    (7) The provision in proposed Sec. 101.17(g)(6) (now 
Sec. 101.17(g)(7)) establishing the processing standard for juices to 
be exempt from the warning statement requirement has been broadened. It 
now includes juice processed in a manner that will achieve or exceed 
any pathogen reduction performance standard established in any final 
regulation requiring the application of HACCP principles to the 
processing of juice.

VIII. Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866. Executive Order 12866 directs Federal agencies to assess 
the costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). According 
to Executive Order 12866, a regulatory action is ``significant'' if it 
meets any one of a number of specified conditions, including having an 
annual effect on the economy of $100 million or adversely affecting in 
a material way a sector of the economy, competition, or jobs or if it 
raises novel legal or policy issues. FDA finds that this final rule is 
a significant regulatory action as defined by Executive Order 12866.
    In addition, FDA has determined that this rule is not a significant 
rule under the Unfunded Mandates Reform Act of 1995 (UMRA) requiring 
benefit-cost and other analyses. Under UMRA significant rule is defined 
as ``a Federal mandate that may result in the expenditure by State, 
local and tribal governments in the aggregate, or by the private 
sector, of $100,000,000 (adjusted annually for inflation) in any 1 
year.''
    Finally, in accordance with the Small Business Regulatory 
Enforcement and Fairness Act, the Administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget (the Administrator) has determined that this final rule is not a 
major rule for the purpose of congressional review. A major rule for 
this purpose is defined as one that the Administrator has determined 
has resulted or is likely to result in an annual effect on the economy 
of $100 million or more; a major increase in costs or prices for 
consumers, individual industries, Federal, State, or local government 
agencies, or geographic regions; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of U.S.-based enterprises to compete with foreign-based 
enterprises in domestic or export markets.
    In the Federal Register of May 1, 1998 (63 FR 24254), FDA published 
a Proposed Regulatory Impact Analysis (PRIA) analyzing the benefits, 
costs, and regulatory options of proposed regulations regarding warning 
statement requirements and HACCP for juice. FDA received several 
comments on the PRIA from juice processors, trade associations, and 
consumers. In this document, FDA is finalizing the labeling provisions. 
FDA intends to publish a final rule on the HACCP requirements at a 
later date. Thus, FDA is only analyzing the impacts of the warning 
statement requirement.

A. Regulatory Alternatives

1. Prohibit Display of Warning Statement on Signs
    FDA received several comments objecting to the proposed provisions 
that would temporarily allow the use of signs or other labeling to 
communicate the warning statement.
    65. Several comments stated that FDA did not accurately address the 
costs or benefits of this proposed provision. For example, some 
comments asserted that signs with the warning statement will 
communicate that all of the juice in a refrigerated case is subject to 
the warning statement and thereby impose costs on processors of 
pasteurized juice. Some other comments said that signs with the warning 
statement may not be close enough to the product to be effective in 
achieving the benefits that the agency seeks. FDA believes that the 
problems mentioned by these comments will not be significant. Both 
retailers and sales representatives of products to which the warning 
statements do not apply have a financial interest in ensuring that the 
warning statements (particularly in sign or placard form) are not used 
in a way that would create the appearance that the warning statement 
applies to a broader set of products than required by this rule. For 
example, retailers may place signs on individual shelves rather than 
over entire refrigerated cases. In some stores that do sell untreated 
juice, the untreated juice products are sold in separate refrigerators 
in the produce section while pasteurized juice is sold with the other 
refrigerated products. Thus, products that need to be accompanied by 
the warning statement may be physically separated from other juices. 
Also, the sign or placard could specify by name the products covered by 
the warning statement. For these reasons, the agency disagrees with 
these comments and declines to adjust estimates of the benefits or 
costs of the rule based on them.
2. Require a 5-Log Process
    66. Some comments said that requiring a process to achieve a 5-log 
reduction in pathogens as the alternative to the warning statement on 
untreated juice is too expensive an alternative for small businesses 
that wish to avoid the warning statement. One comment from a small 
juice processor said that implementing pasteurization to achieve a 5-
log reduction would cost $30,000. Some other comments asserted that all 
juice should be required to be pasteurized.
    In the PRIA, FDA provided an estimate of the cost of pasteurization 
equipment developed especially for small juice processors ($18,200). 
The agency does acknowledge that this may be a significant cost for 
some small businesses. Although the agency is encouraging juice 
processors to implement pasteurization or other process controls 
sufficient to achieve a

[[Page 37049]]

5-log reduction in pathogens, FDA is not mandating a 5-log reduction at 
this time. Instead, this final rule permits processors to produce 
untreated juice and offer it for sale accompanied by the warning 
statement until a final HACCP regulation (if one is established) is in 
place. The agency believes that requiring a warning statement on 
untreated juice is the least stringent regulatory approach acceptable 
for untreated juice. Processors (especially processors of very small 
volumes of juice) may find that including the warning statement on 
untreated juice is a less expensive alternative to implementing a 5-log 
pathogen reduction process.
    However, as noted, FDA believes that requiring pasteurization of 
all juice would unnecessarily restrict innovation and new product 
development. Such activities are important to maintain competitiveness 
in the food industry. Additionally, the agency believes that consumer 
choice would be unnecessarily restricted by requiring all firms to 
implement a single type of processing technology. Until the agency has 
the opportunity to review all comments received in response to the 
HACCP proposal, the agency is satisfied that the proposed approach is 
the best balance between achieving the intended benefits and allowing 
flexibility for production.
3. Require Preventive Controls
    67. Some comments suggested that FDA should implement GMP or HACCP 
(preventive control) requirements immediately rather than require 
warning statements on untreated juice products. Other comments 
supported the use of a warning statement on food products only as an 
interim measure until the agency establishes a more comprehensive 
solution to the problem of microbial contamination in juice. FDA 
recognizes the importance of preventive controls and has tentatively 
concluded that it is essential to implement a HACCP regulation for 
juice. The agency also believes that it is essential to communicate the 
risks associated with untreated juice to consumers during the 
considerable amount of time that will be required for the agency to 
finalize and implement an inherently more complex HACCP regulation for 
juice.
4. Require Brochures
    68. As described earlier, some comments supported the use of 
brochures or pamphlets outlining the risks associated with the 
consumption of untreated juices as an alternative to a label warning 
statement. FDA declines to require brochures as an alternative in this 
rule because the focus group research shows that brochures would 
generate fewer benefits than the approach taken in this rule. FDA 
further notes that requiring the distribution of a brochure with each 
package of juice is likely to be at least as costly as placing stickers 
on each package label.
5. Change Length of Time Signs are Allowed
    69. Some comments opposed the length of time that signs with the 
warning statement would be allowed (until January 1, 2000, the next 
uniform compliance date for other food labeling changes and until 
January 1, 2001 for small businesses) under the proposed rule. These 
comments claimed that signs would be less effective than labels in 
communicating the warning information.
    FDA finds merit in these comments. The agency agrees that placards 
and signs may be less effective than package labels for the purpose of 
communicating product-specific information to consumers. However, as a 
practical matter, producers of untreated juice need time to modify 
their package labels to include the warning statement. In response to 
the concerns about the effectiveness of signs and placards, in this 
final rule, FDA is reducing the length of time that the warning 
statement may be provided in labeling such as signs or placards. FDA 
has concluded that a full juice season provides all firms, whether 
large or small, sufficient time to comply with the label requirement. 
Accordingly, this final rule provides that the required label statement 
may be provided in labeling at point of purchase, for a period of 1 
year from the date for compliance with the final rule. The interim use 
of signs, placards, or other labeling for 1 year from the date when 
compliance is required will, in essence, provide manufacturers the 
flexibility to use labeling for a single juice season.

B. Benefits

1. Estimates of Juice Consumption
    70. One comment stated that FDA had underestimated the amount of 
untreated juice consumed and, therefore, had underestimated the number 
of cases of illness that would be addressed by the rule. FDA disagrees 
that the cases of illness addressed by the rule have been 
underestimated as a result of the agency's consumption estimates. FDA 
did not estimate the number of cases of illness based on consumption; 
instead, the agency estimated the number of cases of illness by 
multiplying confirmed illnesses associated with juice by factors 
accounting for the under reporting on foodborne illness. Thus, FDA does 
not agree with this comment.
2. Recent Activity Not Accounted For
    71. Some comments asserted that the agency's estimates of illness 
are outdated because these estimates do not take into account the 
recent steps that the industry and State governments have taken to 
reduce risk associated with juice.
    FDA has used the most up-to-date information available on foodborne 
illness associated with juice. Complete data from the Centers for 
Disease Control and Prevention for 1997 are not available. The agency 
acknowledges that industry and State governments have been working to 
reduce the public health risks associated with consumption of untreated 
juice, and FDA encourages these efforts and hopes that they continue. 
However, because FDA has no evidence that the industry and State 
government efforts have sufficiently minimized the risk associated with 
juice, the agency believes that the warning statement is needed to 
inform the choices of consumers. Further, the rule will provide an 
incentive to continue to improve upon these efforts. Where these 
efforts of industry achieve a 5-log reduction in pathogens, those 
processors using such processes are not required to apply the warning 
statement to their products.
3. Value of Information
    72. Some comments said that consumers would value the information 
in the warning statement because it would increase their ability to 
make informed choices.
    FDA agrees that to the extent that the warning statement lowers the 
cost to consumers of obtaining information, there is a benefit to 
consumers in addition to the reduction in illnesses estimated in the 
PRIA. Although FDA is unable to quantify this benefit, it is 
appropriately counted as an unquantified benefit of the final rule.
4. Impact of Warning Statement on Lawsuits
    73. One comment claimed that the warning statement will protect 
processors from lawsuits and bad publicity because consumers of the 
product will be taking responsibility for the risk associated with the 
product. Another comment said that the warning statement will encourage 
more lawsuits because the warning statement will suggest to consumers 
that the juice may be the cause of their symptoms.
    State liability laws and their interpretations vary. These 
conflicting comments provided no specifics on these issues. FDA is not 
able to evaluate the impact of the warning statement on the filing or 
adjudication of lawsuits. For this reason, the agency has not made

[[Page 37050]]

any changes to the benefits or costs estimated for this rule based on 
these comments.
5. Benefits Summary
    Table 1 shows the quantified benefits estimated for the labeling 
rule in both the PRIA and Final Regulatory Impact Analysis (FRIA (see 
section VIII of this document)). No comments persuaded the agency to 
change the quantified benefits of the rule. There are two additional 
unquantified benefits that, as a result of comments, the agency 
acknowledges. The first unquantified benefit is the value of the 
warning information to consumers regardless of changes in their 
consumption patterns; the agency is unable to quantify this benefit. 
Second, the agency believes that there will be some increase in 
benefits resulting from requiring the warning statement on package 
labels sooner than originally proposed; the agency is unable to 
quantify this benefit.

Table 1.--Quantified Benefits for Labeling Rule as Estimated in PRIA and
                                  FRIA                                  
------------------------------------------------------------------------
                                          PRIA high         FRIA high   
PRIA low estimate  FRIA low estimate      estimate          estimate    
------------------------------------------------------------------------
$1 million         $1 million         $6 million        $6 million      
------------------------------------------------------------------------

C. Costs

1. Effect of Warning Statement on Untreated Juice Sales
    FDA received comments regarding the impact of the warning statement 
on sales of untreated juice. These effects stem from either consumer 
reaction, retailer response, or both.
    74. Some comments said that the warning statement will have a 
negative effect on sales of untreated juice. FDA acknowledges this 
possible effect. In fact, the agency intends for the warning statement 
to reduce the consumption of untreated juice by consumers who are most 
at risk. The inevitable consequence of this goal is to have a negative 
effect on the sales of untreated juice.
    FDA received one comment demonstrating that a market for 
unpasteurized juice does exist and may not be significantly harmed by 
the warning statement requirement of this rule. This comment from a 
juice processor stated that he produces both pasteurized and 
unpasteurized cider. The unpasteurized cider is sold accompanied by a 
leaflet warning consumers of the risk associated with untreated juice. 
This processor reports that 70 percent of his sales continue to come 
from unpasteurized cider.
    FDA applauds this processor's responsible actions. The agency is 
not, in this rule, prohibiting the sale of untreated juice, nor does 
the agency believe that the warning statement will dissuade all 
consumers from purchasing untreated juice. FDA believes that at-risk 
consumers should carefully consider the consumption of untreated juice 
and the availability of the warning statement will allow informed 
decisionmaking by consumers. It is quite possible that this processor 
will see no change in the demand for either type of juice as a result 
of this rule, since the processor was already providing consumers with 
the warning information and offering them a product that has been 
subject to a 5-log reduction in pathogens. In fact, the agency believes 
that the experience of this processor shows that this rule will not 
have the extreme consequences described by some of the comments.
    75. Some comments said that the warning statement will confuse 
consumers, that at-risk consumers will not be deterred from consuming 
untreated juice, and that consumers who are not at risk will be 
deterred from consuming juice.
    FDA disagrees with these comments because the agency believes that 
the warning statement communicates a clear, appropriately targeted 
message. Importantly, the agency does not claim that all at-risk 
consumers will stop consuming untreated juice. FDA's estimates of 
consumption changes range from an expected 5 percent to a maximum of 16 
percent. The comments that referred to a larger than 16 percent decline 
in consumption and sales during the last cider season were based on the 
effects of adverse publicity surrounding the outbreaks associated with 
untreated apple juice and cider, not on the effects of labeling. Any 
costs that resulted from adverse publicity that occurred before the 
agency first became involved in this issue are not attributable to this 
rulemaking. FDA believes that the decline in sales experienced by some 
producers in response to adverse general publicity are not indicative 
of the potential effects of labeling that provides true and not 
misleading information. Moreover, these sales declines have already 
occurred and cannot occur again for the same processors. However, the 
agency acknowledges that some consumers who are not at high risk may 
choose not to purchase untreated juice because of the warning 
statement. The agency believes that consumers are better off whenever 
they make better informed choices, and that better informed choices 
demonstrate unambiguously an increase in net societal benefits.
    76. Some comments from juice processors said that retailers will 
refuse to sell products with warning statements. Some comments said 
that virtually all chain and large grocery stores have stopped selling 
untreated apple juice because of the publicity of the illnesses 
associated with untreated apple juice. In addition, some comments from 
citrus processors said that retailers would refuse to carry citrus 
juice with the warning statement just as apple juice processors have 
experienced. These comments stated that they expected a 50 percent 
reduction in sales because retail stores would not even offer consumers 
the choice of untreated juice with the warning statement. Some comments 
said, because of their concern that the warning labels will have a 
negative impact on citrus juice (including pasteurized as well as 
citrus fruit sold), that the warning statement would cause catastrophic 
damage to the Florida citrus industry.
    FDA acknowledges that retailers may have this reaction to juice 
products with the warning statement. Like consumers who may decide not 
to purchase untreated juice because of the warning statement, retailers 
may decide not to buy untreated juice from wholesalers or processors 
for retail sale. The agency believes that the warning statement will 
have a minor effect on the choice of retailers to carry untreated juice 
products. For the most part retailers have already made a decision 
about carrying untreated apple juice based on the publicity of the 
illnesses associated with untreated apple juice. Also, the agency's 
estimates of the impact of the juice HACCP and warning statement 
proposals in the PRIA were based on the agency's conjecture that citrus 
processors may be able to achieve and validate a 5-log reduction 
without pasteurization (63 FR 20450 at 20478). If processors of 
untreated citrus juices are able to accomplish this then the citrus 
industry will experience little effect of this warning statement rule 
because citrus juices would then not require the warning statement. The 
agency does not believe that this rule

[[Page 37051]]

will have a significant impact on the citrus industry.
    77. Some comments said that retailers will refuse to place signs 
bearing warning statements so that processors will have to place the 
warning statements on the juice package. One comment representing 
retailers indicated that retailers did not want the agency to permit 
the warning statement to appear on signs.
    If the only issue is whether the warning statement appears on signs 
or on package labels, then retailers could make it a condition of sale 
that the warning statement be on the product package so that they do 
not have to deal with signs. The agency believes that these issues are 
best left to the market to determine. Regardless of how these issues 
are resolved, they do not result in costs of the rule that should be 
included in the FRIA.
    A reduction in sales of untreated juice as a result of the warning 
statement is not a social cost of the rule if the effect of the warning 
statement is to restore consumers to a correct understanding of the 
actual risk posed by consumption. In fact, all estimated gains to 
public health reflect the agency's belief that the effect of the 
warning statement is to enable consumers to more correctly account for 
this risk. However, if the warning statement results in exaggerated 
consumer risk perceptions, then the warning statement would result in 
excess reduction in the demand for untreated juice and new, unintended 
social costs. These new social costs would include reductions in both 
consumers' and producers' surplus. Thus, the magnitude of net social 
benefit depends on the extent to which the warning statement changes 
consumer risk perceptions so as to result in a new demand that 
overshoots or undershoots the socially optimal demand.
2. Effect of Warning Statement on Pasteurized Juice Sales
    78. Some comments asserted that the warning statement will have a 
negative effect on the sales of pasteurized juice. One comment stated 
that the warning label would eliminate the competitive edge that 
untreated juice has over pasteurized juice. Another comment said that 
the warning statement will eliminate consumer confusion about the 
difference in risk between pasteurized and unpasteurized products.
    FDA agrees that the warning statement referring specifically to 
unpasteurized products will provide consumers with more information and 
increase consumers' ability to make informed choices between the two 
types of juice. Comments that claimed that the warning statement would 
negatively affect sales of pasteurized juice provided no information or 
other justification for such statements. Likewise, the agency is 
unaware of any research showing that warning statements referring to 
one type of product have a negative impact on the sale of products to 
which the warning statement does not apply. FDA agrees with the comment 
that untreated juice will lose some competitive advantage with 
pasteurized juice. In fact, FDA believes it likely that the warning 
statement will have a small but positive effect on sales of pasteurized 
juice because the most likely alternative for consumers who wish to 
avoid juices covered by the warning statement (i.e., untreated juice) 
is the purchase and consumption of pasteurized juice, because the 
closest substitute for unpasteurized juice is probably pasteurized 
juice.
3. Effect of Warning Statement on International Trade
    79. Some comments said that the warning statement could act as a 
non-tariff trade barrier both to U.S. processors who are interested in 
exporting untreated juice and to foreign processors who import 
untreated juice into the United States.
    FDA disagrees with these comments. This rule is not a prohibited 
trade barrier. U.S. trade obligations permit the agency to establish 
measures that regulate the safety of imported foods as long as the 
measures are consistent with the Sanitary and Phytosanitary (SPS) 
agreement. Trade agreements administered by the World Trade 
Organization (WTO) require that WTO members not apply measures that are 
more restrictive to imported goods than to domestic goods, without 
science-based justification. This is not the case with this rule. 
Further the trade agreements require that measures be based on risk 
assessment, appropriate to the circumstances, taking into account 
available scientific information, relevant processes and production 
methods; and other relevant factors. The agency believes it carried out 
a comprehensive and science-based evaluation of the risks in making its 
decision to require a warning statement. The agency recognizes that its 
decision can impact trade, but believes that the resulting measure is 
fully consistent with the rights and obligations of the WTO agreements.
4. Cost of Label Change
    80. Some comments stated that the warning statement should appear 
on product labels within 60 days of publication of the final rule. 
These comments said that label changes could be made by very small 
businesses easily, quickly, and at very low cost. Some other comments 
said that if the warning statement were required to be included on 
product labels this season, processors would suffer extreme hardship 
and expense. These comments requested more time before the warning 
statement is required to be placed on labels.
    In the PRIA, FDA estimated the cost of label changes for compliance 
periods of different lengths. In light of these conflicting comments, 
the agency has further considered the costs of including the warning 
statement on package labels. As a result of these investigations, FDA 
is revising the estimate of the administrative costs of the label 
change in the case of this rule.
    The comments outlined the activities and changes that are specific 
to the juice warning statement situation and identified the activities 
involved for this rule that are different from those for most label 
changes. The estimate for administrative costs in the PRIA was based on 
a model for calculating costs of labeling changes based on more 
comprehensive changes in food labels. FDA is convinced that the label 
change involved in this specific rule is simpler and therefore requires 
a lesser effort (Ref. 14). Because the agency is prescribing the exact 
words to be used in the warning statement and because affected 
processors have been so significantly alerted to FDA's intent to 
establish the rule, the administrative costs of determining the need to 
and manner in which to comply should be greatly reduced from other 
labeling change situations. FDA estimates that the administrative costs 
of making this label change would require 8 labor hours. At $13 per 
labor hour, the estimated administrative cost is approximately $100 for 
a 1-year compliance period. Table 2 shows the label change costs for 
different compliance periods as estimated in the PRIA and in this FRIA.

[[Page 37052]]



         Table 2.--Integrated Label Change Costs per SKU for Different Lengths of the Compliance Period         
----------------------------------------------------------------------------------------------------------------
      Item         2 Months PRIA   2 Months FRIA   6 Months PRIA   6 Months FRIA    1 Year PRIA     1 Year FRIA 
----------------------------------------------------------------------------------------------------------------
Administrative                                                                                                  
 Costs             $6,000            $700          $1,800            $200            $900            $100       
Redesign Costs     $1,500          $1,500            $450            $450            $450            $450       
Inventory Loss       $800            $800            $250            $250              $0              $0       
Total Integrated                                                                                                
 Labels            $8,300          $3,000          $2,500            $900          $1,350            $550       
----------------------------------------------------------------------------------------------------------------

    81. Some comments suggested that stickers could be used to 
supplement existing labels within 2 months. The agency has investigated 
the cost of using stickers to augment the package labels so as to 
include the warning statement on packages without changing labels 
existing in inventory. Stickers would result in no redesign or 
inventory loss. However, there would be administrative costs for 
designing, ordering and coordinating placement of the stickers. The 
agency believes that the administrative cost for using stickers is 
significantly lower than that for integrated label changes in the same 
period of time. In addition to administrative costs, use of stickers 
would result in costs for printing the stickers and labor and equipment 
needed to apply the stickers. Table 3 shows the estimated cost for 
stickers for a very small juice processor producing approximately 
10,000 gallons of juice per season. This size plant is typical of the 
processors likely to be affected by this rule.

                      Table 3.--Label Sticker Costs                     
------------------------------------------------------------------------
                        Item                                 Cost       
------------------------------------------------------------------------
Administrative Costs                                         $100       
Printing Costs                                               $250       
Application Costs                                            $600       
Total Stickers                                             $1,000       
------------------------------------------------------------------------

5. Costs Summary
    FDA has relied on the most recent data available to estimate risks 
of foodborne illness from untreated juice and the costs associated with 
this rulemaking. Information about baseline risk is somewhat older than 
information about cost; hence, estimates of baseline risk do not 
account for changes that may have occurred since public concern about 
the safety of untreated juice arose. However, cost estimates treat as 
``sunk'' those expenditures that firms and consumers have made in 
recent years in response to concerns about the risks associated with 
untreated juice.
    The quantifiable costs of this final rule include the cost of signs 
or placards, earlier implementation of pathogen controls to avoid 
warning statements, and changing container labels to include the 
warning statement.
    In this final rule, FDA is requiring that the warning statement 
appear on products sooner than the proposed rule would have required. 
The costs estimated in the PRIA were based on a 2-year compliance 
period. The costs of label changes estimated in this FRIA are based on 
a 1-year compliance period (2,980 firms x $550 per firm = $1,639,000).
    As discussed earlier, the agency acknowledges one category of 
unquantified costs that result from responses to the comments, 
specifically, the transaction cost of the working of the legal system 
for increased product liability lawsuits. The agency believes this cost 
will be small.
    Table 4 shows the quantified costs estimated for the rule in the 
PRIA and FRIA.

           Table 4.--Costs Estimated for Rule in PRIA and FRIA          
------------------------------------------------------------------------
              Cost                   PRIA Estimate       FRIA Estimate  
------------------------------------------------------------------------
Signs and Placards                   $398,000            $398,000       
Earlier Implementation of                                               
 Pathogen Controls to Avoid                                             
 Warning Statement                 $2,688,000          $2,688,000       
Container Labels                   $1,301,000          $1,639,000       
Total                              $4,387,000          $4,725,000       
------------------------------------------------------------------------

IX. Final Regulatory Flexibility Analysis

    FDA has examined the impacts of this final rule under the 
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C. 
601-612) requires federal agencies to consider alternatives that would 
minimize the economic impact of their regulations on small businesses 
and other small entities. In compliance with the Regulatory Flexibility 
Act (RFA), FDA finds that this final rule will have a significant 
impact on a substantial number of small entities.
    The agency has evaluated comments on the juice labeling proposal 
and on the Preliminary Regulatory Impact Analysis (PRIA) and Initial 
Regulatory Flexibility Analysis (IRFA) on matters that bear on small 
business impacts. The agency's responses to these comments are set out 
in the next section; that section is followed by a summary of the 
estimates of costs of this final rule to small businesses.

A. Responses to Comments

1. Warning Statement Effect on Viability of Small Businesses
    82. Some comments asserted that the warning statement will harm the 
viability of small farm businesses. Some of these comments said that 
the price of purchasing, installing, and operating pathogen controls 
(so as to avoid application of the warning statement) was too much for 
small businesses to pay.

[[Page 37053]]

    FDA acknowledges that the initiation of new pathogen controls may 
be a significant expenditure for some small businesses. However, the 
agency believes that the public health risk associated with untreated 
juice is significant enough to warrant requiring all juice either to be 
subject to pathogen controls or to bear a statement warning consumers 
of the health risks associated with untreated juice. These public 
health risks exist regardless of the size of the producer--small or 
large. Very few untreated juice processors are stand-alone businesses. 
Instead, virtually all are side businesses of orchards that use fruit 
not sent to packing houses for making juice. This primary business--
growing fruit for whole packing--should not be adversely affected by 
this rule.
2. Expense of Label Changes for Small Businesses
    83. As noted, some comments stated that the warning statement 
should be required to appear on product labels within 60 days of 
publication of the final rule. These comments said that label changes 
could be made by very small businesses easily, quickly, and at very low 
cost. Other comments asserted that if the warning statement was 
required to be included on product labels this season, processors would 
suffer extreme hardship and expense. These comments requested more time 
before the warning statement was required to be placed on labels.
    As described in the FRIA above, FDA has revised the estimate of the 
administrative costs of the label change in the case of this rule. The 
agency has determined that it is appropriate to reduce the length of 
time that manufacturers will be permitted to provide the required 
warning statement in labeling, (e.g., on signs and placards) to up to 1 
year from the date for compliance with the rule. This will allow the 
warning statement to appear on signs and placards for one juice season.
3. Coverage of Small Juice Processors
    84. One comment requested that processors of less than 40,000 
gallons of juice annually be exempt from the rule. The comment stated 
that small farmers use untreated juice production as an automatic 
stabilizer to augment their income from the sale of whole fruit, 
probably when growing conditions are bad. According to the comment, not 
all fruit grown in an orchard meets the size, shape and other standards 
necessary for it to be sold as whole fruit. It is not unusual for these 
culls to amount to 10 percent of the harvest; when crop growing 
conditions are less favorable (e.g., due to hail damage), the 
percentage of culls is greater. Farmers may sell culls to large 
processors for processed juice and other highly processed fruit 
products, or they may use culls to produce their own untreated juice. 
The comment asserted that culls used for untreated juice production 
return 300 percent to 400 percent more than culls sold for highly 
processed products. Other comments, however, said that small businesses 
should not be exempt from the rule.
    FDA's labeling proposal did not exempt any juice processors. The 
agency understands that small businesses may lose some income as a 
result of this rule. The agency believes, however, that it is essential 
that consumers be informed of the risk associated with the consumption 
of untreated juice regardless of the size of the processor. The risk 
faced by the consumer is related only to the product and not to the 
size of the product's processor. The agency has sought to craft this 
rule in the most cost-effective manner in order to minimize the rule's 
burden on processors while still attaining the goals of the rule. Given 
this fact, the agency is not aware of any rational basis related to the 
rule's goal that would justify completely excluding small processors 
from the labeling requirement.
4. Level Playing Field for Business
    85. Some comments asserted that the proposed rule gave unfair 
advantages to large corporations. Other comments claimed that the 
proposal would give undue consideration to small businesses. Comments 
on both sides of this issue requested that the agency establish ``a 
level playing field'' for business. FDA interprets a request for a 
``level playing field'' as a request for equitable treatment. The RFA 
(as amended in 1995) and Executive Order 12866 require that FDA address 
the issue of equity. The agency has considered these issues, including 
regulatory alternatives that would reduce the burden on small 
businesses, and has determined that the risks to public health 
associated with untreated juice are such that small processors should 
not be excluded from the labeling requirement.

B. Objectives

    The RFA requires a succinct statement of the purpose and objectives 
of any rule that will have a significant impact on a substantial number 
of small entities.
    This rule responds to the need to alert consumers to the potential 
risk of foodborne illness from consumption of juice products not 
pasteurized or otherwise processed to destroy pathogens that may be 
present; these pathogens pose a risk of serious foodborne illness. FDA 
is requiring warning statements for such juice products to inform 
consumers of the potential hazard of pathogens in such products; such 
labeling is not required for juice that is processed to achieve a 5-log 
reduction in the pertinent microorganism. If FDA finalizes a rule 
requiring the application of HACCP principles to the processing of 
juice, the warning statement will no longer be required for those 
products that achieve a pathogen reduction that is equal to, or greater 
than, the standard established in a HACCP final rule.

C. Definition of Small Business and Number of Small Businesses Affected

    The RFA requires a statement of the definition of small business 
used in the analysis and a description of the number of small entities 
affected.
    Table 5 shows the definition of small business for each type of 
establishment affected by the rule and an estimate of the number of 
small entities of each type. The agency has applied the Small Business 
Administration (SBA) definitions of small business for this analysis.

                    Table 5.--Approximate Number of Small Establishments Covered by This Rule                   
----------------------------------------------------------------------------------------------------------------
                                                                                   Percentage of   No. of Small 
                                    Standard Industry     SBA Definition of Small     Category    Establishments
     Type of Establishment        Classification Codes          by Category          Defined as     Covered by  
                                                                                    Small by SBA       Rule     
----------------------------------------------------------------------------------------------------------------
Juice manufacturers in the OEI  2033, 2037                Less than 500 employees      75%             20       
Roadside-type apple juice       2033, 2037                Less than 500 employees     100%          1,600       
 makers                                                                                                         
Roadside-type orange juice      2033, 2037                Less than 500 employees     100%            300       
 makers                                                                                                         
Grocery stores and              5411                      Less than $20 million        85%          1,100       
 supermarkets processing at                                of annual sales                                      
 point of sale                                                                                                  

[[Page 37054]]

                                                                                                                
Total                                                                                               3,020       
----------------------------------------------------------------------------------------------------------------

D. Description of Impact on Small Entities

1. Costs to Small Entities
    Table 6 shows the average cost for small entities that can 
reasonably predict, based on the proposed rule, that they will be 
required to implement an adequate HACCP program and will therefore 
implement 5-log pathogen controls (to avoid use of the warning 
statement) earlier than they would if the warning statement was not 
required for products without validated 5-log pathogen process 
controls. Table 6 also shows the average cost for small entities that 
will not expect to implement 5-log pathogen controls in the future. 
These entities will be required to adopt the warning statement for 
their products. The private costs to small businesses of the warning 
statement also include the lost revenue that results from a reduction 
in sales. These costs are not societal costs and are therefore not 
included in the costs estimated in the FRIA.

                             Table 6.--Average Cost of Compliance for Small Entities                            
----------------------------------------------------------------------------------------------------------------
                                                                           Cost for Entities   Cost for Entities
                                  Item                                     Covered by HACCP     not Covered by  
                                                                                 Rule             HACCP Rule    
----------------------------------------------------------------------------------------------------------------
Sign or Placard                                                                                      $100       
Container Label Change                                                                               $550       
Lost Sales Resulting From Warning Statement (for 5-16% loss on average                                          
 sales of $20,000)                                                                            $1,000-$3,200     
Early Implementation of 5-Log Pathogen Controls to Avoid Labeling             $16,000                           
Total                                                                         $16,000         $1,650-$3,850     
----------------------------------------------------------------------------------------------------------------

    The impacts that the costs will have on a firm will vary depending 
on the total revenue derived from juice by a firm and the profit 
(return on sales) associated with juice production. Data on food 
manufacturing firms indicates that 75 percent of firms have a return on 
sales of less than 5 percent.
2. Professional Skills Required for Compliance
    The RFA requires a description of the professional skills required 
for compliance with this rule. Compliance will require managerial 
skills necessary to design, order, and utilize signs and labels.
3. Recordkeeping Requirements
    The RFA requires a description of the recordkeeping requirements of 
the rule. There are no recordkeeping requirements.

E. Description of Outreach to Small Entities

    The RFA requires a description of the outreach activities taken by 
the agency to inform small entities about the rule and to encourage 
comments from small businesses.
    In addition to publishing the proposed rule in the Federal 
Register, the agency published the rule on the FDA world-wide web site 
to make the text of the rule more easily and widely accessible. The web 
site contains instructions about how to submit comments to the agency. 
FDA officials have on several occasions made speeches and presentations 
at meetings where small entities have been represented by trade 
associations, legal counsel, and academic juice specialists who are 
providing assistance to small entities for commenting and complying. 
FDA has also made a number of special mailings of the rule to small 
entities requesting individual paper copies and has fielded a number of 
phone inquiries about the rule.

F. Minimizing the Burden on Small Entities

    The RFA requires an evaluation of any regulatory overlaps and 
regulatory alternatives that would minimize the costs to small 
entities.
1. On Requiring a 5-Log Process
    86. Some comments said that requiring a process to achieve a 5-log 
reduction in pathogens as the alternative to the warning statement on 
untreated juice was too expensive an alternative for small businesses 
that wish to avoid the warning statement. One comment asserted that 
implementing pasteurization to achieve a 5-log reduction would cost 
$30,000. Other comments claimed that all juice should be required to be 
pasteurized.
    In the PRIA, FDA provided an estimate of the cost of pasteurization 
equipment developed especially for small juice processors ($18,200). 
The agency understands that this may be a significant cost for some 
small businesses. Although the agency is encouraging juice processors 
to implement pasteurization or other process controls sufficient to 
achieve a 5-log reduction in pathogens, at this time, FDA is not 
mandating a 5-log reduction. Instead, this final rule permits 
processors to produce untreated juice and offer it for sale accompanied 
by the warning statement until a final HACCP regulation (if one is 
established) requires such processors to implement process controls 
sufficient to achieve a 5-log reduction in pathogens. The agency 
believes that requiring a warning statement on untreated juice is the 
least stringent regulatory approach acceptable for untreated juice. 
Processors (especially processors of very small volumes of juice) may 
find that including the warning statement on untreated juice is a less 
expensive alternative to implementing a 5-log pathogen reduction 
process.
    However, as noted earlier, FDA believes that requiring 
pasteurization of all juice would unnecessarily restrict innovation and 
new product and process development. Such activities

[[Page 37055]]

are important to maintain competitiveness in the food industry. 
Additionally, the agency believes that consumer choice would be 
unnecessarily restricted by requiring all firms to implement a single 
type of processing technology. At this time, the agency is satisfied 
that the proposed approach is the best balance between achieving the 
intended benefits to consumers and allowing flexibility for production.
2. Change Length of Time Signs are Allowed for Small Businesses
    The proposed rule would have allowed the use of signs or placards 
until January 1, 2000, the next uniform compliance date for other food 
labeling changes, and until January 1, 2001 for small businesses to 
relieve the burden on such businesses.
    87. Some comments opposed the length of time that signs with the 
warning statement would be permitted. These comments asserted that 
signs would be less effective than labels in communicating the hazard 
information. Some of these comments also opposed the additional time 
allowed for small businesses to comply with the requirement that the 
warning statement appear on the labels of their products. The comments 
asserted that the public health concern with untreated juice existed 
whether the producing firm was large or small. Other comments supported 
giving small businesses additional time to place warning statements on 
packages.
    The agency agrees that placards and signs may be somewhat less 
effective than labels for the purpose of communicating product-specific 
information to consumers. However, as a practical matter, producers of 
untreated juice need time to modify their labels to include the warning 
statement. In response to the concerns about the effectiveness of signs 
and placards, in this final rule, FDA is reducing the length of time 
that manufacturers will be allowed to provide the warning statement in 
labeling. The label change is not complex. FDA believes that small 
businesses will not experience more difficulty than large businesses in 
making the change. Therefore, FDA is giving small and large businesses 
the same amount of time to make the change. Accordingly, this final 
rule provides that the required warning statement may be provided in 
labeling at point of purchase until 1 year from the date that firms 
must comply with the requirements of the final rule. The interim use of 
labeling (e.g., signs or placards) for 1 year will, in essence, provide 
manufacturers the option of using labeling for a single juice season.

G. Summary of Regulatory Flexibility Analysis

    FDA has examined the impact of the rule on small businesses in 
accordance with the RFA. This analysis, together with the FRIA and 
remainder of the preamble, constitutes the Final Regulatory Flexibility 
Analysis. FDA has determined that this rule will have a significant 
impact on a substantial number of small entities.

X. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (63 FR 20486 at 20491). No 
new information or comments have been received that would affect the 
agency's previous determination that this action is of a type that does 
not individually or cumulatively have a significant impact on the human 
environment (21 CFR 25.30(k)). Thus, neither an environmental 
assessment nor an environmental impact statement is required.

XI. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this document are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the 
warning statement is ``public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

XII. References

    1. Williams, R., T. Wilcox, B. Timbo, D. Street, C. Nardinelli, 
P. McCarthy, G. Jackson, M. T. Hendricks, and E. Elliot, 
``Preliminary Investigation Into the Morbidity and Mortality Effects 
Associated With the Consumption of Fruit and Vegetable Juices,'' 
October 31, 1997.
    2. Miller, A. J., R. C. Whiting, and J. L. Smith, ``Use of Risk 
Assessment to Reduce Listeriosis Incidence,'' Food Technology, 
51:100-103, 1997.
    3. FDA memorandum, ``Consumer Awareness of Unpasteurized Juice 
as a Risk,'' Brenda M. Derby to Elizabeth Campbell, June 22, 1998.
    4. Stewart, D. W. and I. M. Martin, ``Intended and Unintended 
Consequences of Warning Messages: A Review and Synthesis of 
Empirical Research,'' Journal of Public Policy and Marketing, 
13(1):1-19, 1994.
    5. FDA memorandum, Alan S. Levy to Kenneth Falci, June 26, 1997.
    6. FDA memorandum, ``Consumer Awareness of Voluntary Labeling,'' 
Brenda M. Derby to Elizabeth Campbell, June 22, 1998.
    7. Fratamico, P. M., M. Y. Deng, T. P. Strobaugh, S. A. Palumbo, 
``Construction and Characterization of Escherichia coli 0157:H7 
Strains Expressing Firefly Luciferase and Green Fluorescent Protein 
and Their Use in Survival Studies,'' Journal of Food Protection, 
60(10):1167-1173, 1997.
    8. FDA Memorandum, Robert L. Buchanan to the Record, June 15, 
1998.
    9. Centers for Disease Control, ``Salmonella typhimurium 
Outbreak Traced to a Commercial Apple Cider--New Jersey,'' Morbidity 
and Mortality Weekly Report, 24:87-88, 1975.
    10. Centers for Disease Control and Prevention, ``Outbreaks of 
Escherichia coli O157:H7 Infection and Cryptosporidiosis Associated 
With Drinking Unpasteurized Apple Cider--Connecticut and New York, 
October 1996,'' Morbidity and Mortality Weekly Report, 46(1):4-8, 
1997.
    11. Miller, L. G. and C. W. Kaspar, ``Escherichia coli 0157:H7 
Acid Tolerance and Survival in Apple Cider,'' Journal of Food 
Protection, 57(6):460-464, 1994.
    12. Centers for Disease Control and Prevention, ``Outbreak of 
Escherichia coli O157:H7 Infections Associated with Drinking 
Unpasteurized Commercial Apple Juice--British Columbia, California, 
Colorado, and Washington, October 1996,'' Morbidity and Mortality 
Weekly Report, 45(44):975, 1996.
    13. FDA Memorandum, David Zorn to Elizabeth Campbell, June 18, 
1998.
    14. FDA Memorandum, David Zorn to The Record, June 19, 1998.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.

    2. Section 101.17 is amended by adding paragraph (g) to read as 
follows:


Sec. 101.17   Food labeling warning and notice statements.

* * * * *
    (g) Juices that have not been specifically processed to prevent, 
reduce, or eliminate the presence of pathogens. (1) For purposes of 
this paragraph (g), ``juice'' means the aqueous liquid expressed or 
extracted from one or more fruits or vegetables, purees of the edible 
portions of one or more fruits or vegetables, or any concentrate of 
such liquid or puree.
    (2) The label of:
    (i) Any juice that has not been processed in the manner described 
in paragraph (g)(7) of this section; or

[[Page 37056]]

    (ii) Any beverage containing juice where neither the juice 
ingredient nor the beverage has been processed in the manner described 
in paragraph (g)(7) of this section, shall bear the following warning 
statement:
    WARNING: This product has not been pasteurized and, therefore, 
may contain harmful bacteria that can cause serious illness in 
children, the elderly, and persons with weakened immune systems.
    (3) The warning statement required by this paragraph (g) shall not 
apply to juice that is not for distribution to retail consumers in the 
form shipped and that is for use solely in the manufacture of other 
foods or that is to be processed, labeled, or repacked at a site other 
than originally processed, provided that for juice that has not been 
processed in the manner described in paragraph (g)(7) of this section, 
the lack of such processing is disclosed in documents accompanying the 
juice, in accordance with the practice of the trade.
    (4) The warning statement required by paragraph (g)(2) of this 
section shall appear prominently and conspicuously on the information 
panel or on the principal display panel of the label of the container, 
except that:
    (i) For apple juice or apple cider, the warning statement may 
appear in labeling, including signs or placards, until September 8, 
1999;
    (ii) For all juices other than apple juice or apple cider, the 
warning statement may appear in labeling, including signs or placards, 
until November 5, 1999.
    (5) The word ``WARNING'' shall be capitalized and shall appear in 
bold type.
    (6) The warning statement required by paragraph (g)(2) of this 
section, when on a label, shall be set off in a box by use of 
hairlines.
    (7)(i) The requirements in this paragraph (g) shall not apply to a 
juice that has been processed in a manner that will produce, at a 
minimum, a reduction in the pertinent microorganism for a period at 
least as long as the shelf life of the product when stored under normal 
and moderate abuse conditions, of the following magnitude:
    (A) A 5-log (i.e., 100,000-fold) reduction; or
    (B) A reduction that is equal to, or greater than, the criterion 
established for process controls by any final regulation requiring the 
application of Hazard Analysis Critical Control Points (HACCP) 
principles to the processing of juice.
    (ii) For the purposes of this paragraph (g), the ``pertinent 
microorganism'' is the most resistant microorganism of public health 
significance that is likely to occur in the juice.

    Dated: July 2, 1998.
Michael A. Friedman,
Acting Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 98-18287 Filed 7-6-98; 3:34 pm]
BILLING CODE 4160-01-F